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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02030249
Registration number
NCT02030249
Ethics application status
Date submitted
12/12/2013
Date registered
8/01/2014
Date last updated
30/04/2021
Titles & IDs
Public title
Sub-Study of the PREVIEW Study Australia
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Scientific title
Sub-Study of the PREVIEW Study Australia: Effects of Weight Loss on Appetite, Bone Mass and Muscle Strength
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Secondary ID [1]
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KBBE-CALL- 6-Nr. 312057
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Secondary ID [2]
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2013/535 - SUB-STUDY
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes
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Obesity
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Condition category
Condition code
Metabolic and Endocrine
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Metabolic disorders
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Metabolic and Endocrine
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Diabetes
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Low calorie diet administered from 0 to 2 months
Behaviour - High Protein / Low Glycaemic Index
Behaviour - Moderate Protein / High Glycaemic Index
Experimental: High Protein / Low Glycaemic Index - A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 25% of energy intake, carbohydrate intake is 45% of energy intake, dietary glycaemic index is < 55. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview&rank=1
Active Comparator: Moderate Protein / High Glycaemic Index - A 10-month weight maintenance diet, administered from the 2-month to the 12-month time point, where protein intake is 15% of energy intake, carbohydrate intake is 55% of energy intake, dietary glycaemic index is > 65. Please see parent study for further Arm details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview&rank=1
Behaviour: Low calorie diet administered from 0 to 2 months
The 2-month low calorie diet is administered from the 0 months to the 2 months time point. It is designed to elicit a weight loss of 8% of initial body weight. Please see parent study for further intervention details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview&rank=1
Behaviour: High Protein / Low Glycaemic Index
Please see description of the Arm by the same name.
Behaviour: Moderate Protein / High Glycaemic Index
Please see description of the Arm by the same name.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Fasting appetite
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Assessment method [1]
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Previous research has shown that a weight reducing diet increases appetite in the fasting state. There is some suggestion that this diet-induced increase in appetite is sustained even after following a weight maintenance diet for 12 months. We will assess fasting appetite using visual analogue scales after commencement of the standardized weight loss diet. This primary outcome will demonstrate whether the weight-loss-induced increase in fasting appetite that is anticipated at completion of the diet will be normalized by the 12 month time point, and whether the type of weight maintenance diet (High Protein / Low Glycaemic Index versus Moderate Protein / High Glycaemic Index) influences this.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Bone mass
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Assessment method [2]
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We will assess bone mineral density and bone mineral content in the lumbar spine and hip (or wrist for people in whom arthritis interferes with the reading) via dual energy X-ray absorptiometry (DXA) at 2 months after commencement of the standardized weight loss diet. This primary outcome will help determine whether there is a difference between younger and older participants with respect to changes in bone mass with weight reduction, and whether the type of weight maintenance diet influences this.
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Timepoint [2]
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2 months
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Secondary outcome [1]
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Fasting appetite
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Assessment method [1]
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Timepoint [1]
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0 months
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Secondary outcome [2]
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Fasting appetite
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Assessment method [2]
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Timepoint [2]
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2 months
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Secondary outcome [3]
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Fasting appetite
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Assessment method [3]
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Fasting appetite
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Assessment method [4]
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Fasting appetite
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Assessment method [5]
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Timepoint [5]
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36 months
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Secondary outcome [6]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [6]
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Previous research has shown that a weight reducing diet alters fasting plasma concentrations of gut-derived appetite regulating hormones in a way that would be expected to increase appetite (i.e. increased ghrelin and decreased peptide YY). We will assess fasting plasma concentrations of gut-derived appetite-regulating hormones (ghrelin and peptide YY).
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Timepoint [6]
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0 months
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Secondary outcome [7]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [7]
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Timepoint [7]
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2 months
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Secondary outcome [8]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [8]
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Timepoint [8]
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6 months
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Secondary outcome [9]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [9]
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Timepoint [9]
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12 months
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Secondary outcome [10]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [10]
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Timepoint [10]
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24 months
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Secondary outcome [11]
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Fasting plasma concentrations of gut-derived appetite-regulating hormones
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Assessment method [11]
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Timepoint [11]
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36 months
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Secondary outcome [12]
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Bone mass
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Assessment method [12]
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Timepoint [12]
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0 months
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Secondary outcome [13]
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Bone mass
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Assessment method [13]
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Timepoint [13]
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2 months
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Secondary outcome [14]
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Bone mass
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Assessment method [14]
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Timepoint [14]
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6 months
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Secondary outcome [15]
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Bone mass
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Assessment method [15]
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Timepoint [15]
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24 months
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Secondary outcome [16]
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Bone mass
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Assessment method [16]
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Timepoint [16]
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36 months
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Secondary outcome [17]
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Bone turnover
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Assessment method [17]
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The bone turnover markers to be measured are serum procollagen type-I N-propeptide (P1NP, a marker of bone formation) and serum C-telopeptide of type-I collagen (CTX, a marker of bone resporption). This outcome will enable us to determine whether there is a difference between younger and older participants with respect to changes in bone turnover with weight reduction, and whether the type of weight maintenance diet (High Protein / Low Glycaemic Index versus Moderate Protein / High Glycaemic Index) influences this. This outcome is important because DXA scanning to assess bone mass can result in artefactual results in people with obesity or who are undergoing changes in body fat mass, as will be the case in this trial.
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Timepoint [17]
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0 months
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Secondary outcome [18]
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Bone turnover
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Assessment method [18]
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Timepoint [18]
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2 months
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Secondary outcome [19]
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Bone turnover
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Assessment method [19]
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Timepoint [19]
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6 months
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Secondary outcome [20]
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Bone turnover
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Assessment method [20]
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Timepoint [20]
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12 months
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Secondary outcome [21]
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Bone turnover
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Assessment method [21]
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Timepoint [21]
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24 months
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Secondary outcome [22]
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Bone turnover
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Assessment method [22]
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Timepoint [22]
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36 months
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Secondary outcome [23]
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Modulators of bone turnover
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Assessment method [23]
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Pending funding availability: serum 25-OH vitamin D, serum parathyroid hormone, serum calcium, serum phosphate, serum albumin and serum creatine.
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Timepoint [23]
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0 months
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Secondary outcome [24]
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Modulators of bone turnover
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Assessment method [24]
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Timepoint [24]
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2 months
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Secondary outcome [25]
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Modulators of bone turnover
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Assessment method [25]
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Timepoint [25]
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6 months
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Secondary outcome [26]
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Modulators of bone turnover
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Assessment method [26]
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Timepoint [26]
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12 months
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Secondary outcome [27]
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Modulators of bone turnover
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Assessment method [27]
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Timepoint [27]
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24 months
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Secondary outcome [28]
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Modulators of bone turnover
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Assessment method [28]
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Timepoint [28]
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36 months
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Secondary outcome [29]
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Muscle (handgrip) strength
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Assessment method [29]
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Muscle (handgrip) strength will be determined with a handheld dynamometer. This secondary outcome measure aims to determine whether the standardized weight loss diet induces changes in muscle strength, and whether there is any differential effect in younger versus older participants.
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Timepoint [29]
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0 months
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Secondary outcome [30]
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Muscle (handgrip) strength
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Assessment method [30]
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Timepoint [30]
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2 months
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Secondary outcome [31]
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Muscle (handgrip) strength
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Assessment method [31]
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If the investigators see a change from baseline in muscle (handgrip) strength after the low calorie diet in the younger or older participants, then they will measure muscle (handgrip) strength again at 6 months, to determine whether any such change from baseline is maintained after the two different weight maintenance programs. This secondary outcome will enable determination of whether any effects of the standardized low calorie diet on muscle (handgrip) strength are sustained at 6 months, and whether the type of weight maintenance diet (High Protein / Low Glycaemic Index versus Moderate Protein / High Glycaemic Index) influences this.
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Timepoint [31]
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6 months
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Secondary outcome [32]
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Muscle (handgrip) strength
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Assessment method [32]
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Timepoint [32]
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12 months
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Secondary outcome [33]
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Muscle (handgrip) strength
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Assessment method [33]
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Timepoint [33]
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24 months
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Secondary outcome [34]
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Muscle (handgrip) strength
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Assessment method [34]
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Timepoint [34]
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36 months
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Eligibility
Key inclusion criteria
- Age 25 - 45 years and 55 - 70 years
- Overweight or obesity status BMI>25 kg/m2
- Pre-diabetes. The criteria from WHO/IDF (International Diabetes Foundation) for
assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having:
Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9
mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8
- 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance
test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential
between-lab variation (local assessments), HbA1c is not used as an inclusion criteria
in the screening.
- Informed consent required
- Ethnic group - No restrictions
- Smoking - Smoking is allowed, provided subjects have not recently (within 1 month)
changed habits. However, smoking status is monitored throughout the study and used as
a confounding variable.
- Motivation - Motivation and willingness to be randomized to any of the groups and to
do his/hers best to follow the given protocol
- Other - Able to participate at CID's during normal working hours.
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Minimum age
25
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Based on interview and/or questionnaire, individuals with the following problems will be
excluded:
- Medical conditions as known by the subjects: Diabetes mellitus (other than gestational
diabetes mellitus); Significant cardiovascular disease including current angina;
myocardial infarction or stroke within the past 6 months; heart failure; symptomatic
peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic
blood pressure above 100 mmHg whether on or off treatment for hypertension. If being
treated, no change in drug treatment within last 3 months; Advanced chronic renal
impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed);
Malignancy which is currently active or in remission for less than five years after
last treatment (local basal and squamous cell skin cancer allowed); Active
inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder
potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory,
neurological, musculoskeletal or other disorders where, in the judgement of the
investigator, participants would have unacceptable risk or difficulty in complying
with the protocol (e.g. physical activity program); A recent surgical procedure until
after full convalescence (investigators judgement); Transmissible blood-borne diseases
e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder).
- Medication: Use currently or within the previous 3 months of prescription medication
that has the potential of affecting body weight or glucose metabolism such as
glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are
allowed), psychoactive medication, epileptic medication, or weight loss medications
(either prescription, over the counter or herbal). Low dose antidepressants are
allowed if they, in the judgement of the investigator, do not affect weight or
participation to the study protocol. Levothyroxine for treatment of hypothyroidism is
allowed if the participant has been on a stable dose for at least 3 months.
- Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 %
(increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan,
Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed;
Severe food intolerance expected to interfere with the study; Regularly drinking > 21
alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of
abuse within the previous 12 months; Blood donation or transfusion within the past 1
month before baseline or CID's; Self-reported eating disorders; Pregnancy or
lactation, including plans to become pregnant within the next 36 months; No access to
either phone or Internet (this is necessary when being contacted by the instructor's
during the maintenance phase); Adequate understanding of national language;
Psychological or behavioral problems which, in the judgement of the investigator,
would lead to difficulty in complying with the protocol.
- Laboratory screening: If all of the above criteria are satisfied, the participant is
eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose
concentrations are analyzed immediately (Haemocue). In addition full blood count,
urea, and electrolytes may be analyzed as a further safety evaluation.
- ONLY IF the glucose tolerance test meets the entry criteria for the study, the
remaining samples are sent to the local laboratory for a safety check, with the
following exclusion criteria: Hemoglobin concentration below local laboratory
reference values (i.e. anemia); Creatinine >1.5 times Upper Limit of Normal (local
laboratory reference values); Alanine Transaminase (ALT) and/or Aspartate Transaminase
(AST) >3 times the Upper Limit of Normal (local laboratory reference values); Or any
other significant abnormality on these tests which in the investigators opinion may be
clinically significant and require further assessment.
- Electrocardiography (ECG). Any abnormality which in the opinion of the investigator
might indicate undiagnosed cardiac disease requiring further assessment (e.g.
significant conduction disorder, arrhythmia, pathological Q waves). This is done in
adults 55-70 years of age.
- After LCD phase (in adults): Failure to reach at least 8% weight reduction during the
LCD phase. This leads to exclusion from the intervention.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
292
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The University of Sydney - Camperdown
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Recruitment hospital [2]
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Garvan Institute of Medical Research - Darlinghurst, Sydney
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick, Sydney
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Recruitment postcode(s) [1]
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2006 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst, Sydney
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Recruitment postcode(s) [3]
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2031 - Randwick, Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to investigate possible enduring effects of a standard 2-month
weight loss program on appetite regulation, bone homeostasis and muscle strength in younger
and older adults, as well as the impact of differences in dietary composition during weight
maintenance.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02030249
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Trial related presentations / publications
Sainsbury A, Zhang L. Role of the arcuate nucleus of the hypothalamus in regulation of body weight during energy deficit. Mol Cell Endocrinol. 2010 Mar 25;316(2):109-19. doi: 10.1016/j.mce.2009.09.025. Epub 2009 Oct 12.
Sainsbury A, Zhang L. Role of the hypothalamus in the neuroendocrine regulation of body weight and composition during energy deficit. Obes Rev. 2012 Mar;13(3):234-57. doi: 10.1111/j.1467-789X.2011.00948.x. Epub 2011 Nov 10.
Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
Westerterp-Plantenga MS, Lejeune MP, Nijs I, van Ooijen M, Kovacs EM. High protein intake sustains weight maintenance after body weight loss in humans. Int J Obes Relat Metab Disord. 2004 Jan;28(1):57-64. doi: 10.1038/sj.ijo.0802461.
Brand-Miller JC, Holt SH, Pawlak DB, McMillan J. Glycemic index and obesity. Am J Clin Nutr. 2002 Jul;76(1):281S-5S. doi: 10.1093/ajcn/76/1.281S.
Soenen S, Martens EA, Hochstenbach-Waelen A, Lemmens SG, Westerterp-Plantenga MS. Normal protein intake is required for body weight loss and weight maintenance, and elevated protein intake for additional preservation of resting energy expenditure and fat free mass. J Nutr. 2013 May;143(5):591-6. doi: 10.3945/jn.112.167593. Epub 2013 Feb 27.
Chapman IM. Obesity in old age. Front Horm Res. 2008;36:97-106. doi: 10.1159/000115358.
Westerterp-Plantenga MS, Lemmens SG, Westerterp KR. Dietary protein - its role in satiety, energetics, weight loss and health. Br J Nutr. 2012 Aug;108 Suppl 2:S105-12. doi: 10.1017/S0007114512002589.
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Public notes
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Contacts
Principal investigator
Name
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Amanda Salis (nee Sainsbury), PhD
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02030249
Download to PDF