Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000110482
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
2/02/2016
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Date results provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a meal replacement program for accelerated weight loss and greater program retention.
Scientific title
Evaluating a meal replacement program (Impromy) for accelerated weight loss and greater program retention in overweight adults..
Secondary ID [1] 288269 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 297213 0
Weight loss 297214 0
Condition category
Condition code
Diet and Nutrition 297420 297420 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified Meal Replacement Program (M-MRP):
The M-MRP group will alternate between MF (3 days/week; Monday, Wednesday, Friday) and the Standard-MRP (3 days/week; Tuesday, Thursday, Sunday), with one day where participants can eat freely, i.e. ad libitum (Saturday). On the MF days, participants will consume 2 Impromy meal replacement shakes (1000kJ each) and a ‘meal’ of free vegetables. Participants will follow this intervention for 16 weeks. Compliance will be collected in week 1, 4, 8, 12, 16 using 7-day checklists. Participants will be required to mark yes/no to consumption of the allocated number of meal replacements, snacks, evening meal and the approximate number of cups (to the nearest half cup) of free vegetables consumed. Intake on the ad libitum day will not be assessed. Qualified research dietitians will deliver face to face instructions and support at baseline, week 1 (via telephone) 2,4,6,8,10,12, and 14.
All participants will then be instructed by the study dietitians to follow an 8 week weight maintenance program based on the Live Well Plan (http://www.beefandlamb.com.au/Learn/Online_magazines/The_Live_Well_Plan).
Intervention code [1] 293558 0
Lifestyle
Comparator / control treatment
Standard Meal Replacement Program (S-MRP):
The S-MRP includes a daily regimen of consuming 2-3 meal replacements (1000kJ each) for 2 meals, one balanced meal (~1500kJ) and prescribed snacks (500kJ). Participants will follow this intervention for 16 weeks. At study commencement individual participant’s estimated energy requirements will be calculated using the Schofield equation (using actual body weight), and multiplied by physical activity levels (PAL). This will be reduced by 30% to achieve energy restriction for weight loss. This energy level will then determine the number of meal replacements and allowable 500kJ snacks, and the energy content of the evening meal for the S-MRP dietary prescription. During this intervention all participants will have all meal replacement shakes/bars supplied at no cost, and the participants can choose the flavour and the time they are consumed.
At the end of week 16, all participants will then be instructed by the study dietitians to follow an 8 week weight maintenance program based on the Live Well Plan (http://www.beefandlamb.com.au/Learn/Online_magazines/The_Live_Well_Plan).
Control group
Active

Outcomes
Primary outcome [1] 296981 0
Participant retention in the weight loss program/study, assessed as the final recorded clinic attendance.
Timepoint [1] 296981 0
week 0 & 16
Primary outcome [2] 296982 0
weight loss assessed using calibrated digital scales
Timepoint [2] 296982 0
week 0 & 16
Secondary outcome [1] 319796 0
fasting plasma glucose using commercial assay kits

Timepoint [1] 319796 0
week 0 & 16
Secondary outcome [2] 319797 0
Blood pressure assessed by digital sphygmomanometer
Timepoint [2] 319797 0
week 0, 2,4,8,12,16
Secondary outcome [3] 319798 0
Body composition of fat and lean mass via DEXA and Bioelectric Impedance (BIA)
Timepoint [3] 319798 0
Dexa: week 0 & 16,
BIA: week 0, 2,4,6,8,10,12,14,16.
Secondary outcome [4] 319799 0
Advanced glycation end products assessed by auto fluorescence (AF) in human skin.
Timepoint [4] 319799 0
week 0 & 16
Secondary outcome [5] 319800 0
fecal markers of gut health (microbiome, SCFA, fecal moisture and pH, intestinal permeability)
Timepoint [5] 319800 0
week 0 & 16
Secondary outcome [6] 319802 0
Gut comfort using a survey designed for this study.
Timepoint [6] 319802 0
week 0 and 16.
Secondary outcome [7] 319803 0
DNA biomarkers from whole blood and buccal cells: genetic variants associated with weight loss (Published genetic variants which show a strong association with obesity and/or metabolic disfunction will be genotyped using assays targeted to specific sites (Sequenom or similar) and SNP arrays) and methylation status.
Timepoint [7] 319803 0
week 0 & 16
Secondary outcome [8] 319804 0
Compliance with the dietary protocols will be assessed using 7-day checklists. Participants will be required to mark yes/no to consumption of the allocated number of meal replacements, snacks, evening meal and the approximate number of cups (to the nearest half cup) of free vegetables consumed (collected in week 1,4,8,12 and 16).
Timepoint [8] 319804 0
week 0 & 16
Secondary outcome [9] 319974 0
fasting blood samples for total cholesterol, using commercially available assay kits
Timepoint [9] 319974 0
week 0 and week 16
Secondary outcome [10] 319975 0
fasting blood samples for C reactive protein using commercially available assay kits
Timepoint [10] 319975 0
week 0 and week 16
Secondary outcome [11] 319976 0
fasting, plasma levels of iron assessed by commercial laboratory service provider.
Timepoint [11] 319976 0
week 0 and week 16
Secondary outcome [12] 319977 0
Retinal vascularity as a marker of metabolic health, assessed by retinal scan
Timepoint [12] 319977 0
week 0 and week 16
Secondary outcome [13] 319978 0
Motivation and behavioural control will be assessed using 7 questions, which are based on the Theory of Planned Behaviour, mood will be assessed using the validated 20-item Positive and Negative Affect Schedule, social problem solving inventory, plan quality and dichotomous thinking will be assessed using the validated 15-item Dichotomous Thinking Inventory (DTI), the Social Problem Solving Inventory-Revised and a modified version of the 7-item Goal-Setting Evaluation Tool for Diabetes (GET-D).
Timepoint [13] 319978 0
week 0 and 16
Secondary outcome [14] 319979 0
Health related quality of life will be assessed using the validated The RAND-36 and cohort-term and working memory and speed of processing will be assessed using a short battery of validated tests (5-10 minutes) that can be administered via a computer or tablet.
Timepoint [14] 319979 0
week 0 and 16
Secondary outcome [15] 319980 0
5 validated visual analogue scales will be used to assess food cravings
Timepoint [15] 319980 0
week 0 and 16
Secondary outcome [16] 320337 0
plasma insulin will be measured using commercial assay kits
Timepoint [16] 320337 0
week 0 and week 16
Secondary outcome [17] 320338 0
fasting, plasma levels of zinc assessed by commercial laboratory service provider.
Timepoint [17] 320338 0
week 0 and 16
Secondary outcome [18] 320339 0
fasting, plasma levels of folic acid in erythrocytes, assessed by commercial laboratory service provider.
Timepoint [18] 320339 0
week 0 and 16
Secondary outcome [19] 320340 0
fasting, plasma levels of vitaminD3/25-OH calciferol assessed by commercial laboratory service provider.
Timepoint [19] 320340 0
week 0 and 16
Secondary outcome [20] 320341 0
fasting, plasma levels of vitamin B1assessed by commercial laboratory service provider.
Timepoint [20] 320341 0
week 0 and 16
Secondary outcome [21] 320342 0
fasting, plasma levels of vitamin B12 assessed by commercial laboratory service provider.
Timepoint [21] 320342 0
week 0 and 16
Secondary outcome [22] 320343 0
fasting blood samples for HDL cholesterol using commercially available assay kits
Timepoint [22] 320343 0
week 0 and 16
Secondary outcome [23] 320344 0
fasting blood samples for LDL cholesterol using commercially available assay kits
Timepoint [23] 320344 0
week 0 and 16
Secondary outcome [24] 320345 0
The Dutch Eating Behaviour Questionnaire (DEBQ) will assess eating styles.
Timepoint [24] 320345 0
week 0 and 16

Eligibility
Key inclusion criteria
1.Adults with a BMI greater than or equal to 27kg/m2;
2.Aged 25-60 years;
3.Willing to attend CSIRO SAHMRI clinic in Adelaide on 10 occasions;
4.Willing to participate in the study including collection of blood samples on 2 occasions, and completing questionnaires,
5.Willing to follow a weight loss dietary protocol for 16 weeks plus weight maintenance dietary protocol a further 8 weeks;
6. Non-smoker;
7. Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any known pre-existing, diagnosed medical condition (assessed by self report in the screening medical questionnaire) that may prevent them from participating in the study, including but not limited to:
a. Kidney disease or renal impairment;
b. Gall bladder disorders or stones;
2.Regular use of prescribed weight loss medications; or medications that contain Mono-amine oxidase inhibitors, Lithium, Anticoagulants e.g. Warfarin.
3.Regular use of any other medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
4.A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
5.A score of greater than or equal to 2 on the SCOFF screening questionnaire for eating disorders*;
6.A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;
7.Women who are attempting to become pregnant, pregnant, lactating, (postmenopausal women should not change HRT regimen during the study);
8.Participation in another study within 30 days of commencement of the present study.

a.Liver disease (e.g. cirrhosis);
b.Angina, chest pain (undiagnosed) or severe shortness of breath;
c.Diagnosed cardiovascular disease;
d.Cardiac arrhythmia, heart disease, heart attack, coronary bypass surgery;
e.Stroke;
f.Dementia;
g.Thyroid disease;
h.Gout;
i.Gastrointestinal disease (including celiac or malabsorption diseases Crohns disease);
j.History of bariatric surgery;
k.Epilepsy;
l.Neurological or psychiatric conditions;
m.Severe depression;
n.Cancer (unless benign or non-progressive skin cancer);
o.Type 1 or type 2 diabetes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) with stratification for BMI, age, and sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is calculated using the expected proportion retained in 2 groups using the z family of tests (proportions; G*power ). We will need 82 participants per group to have 80% power to detect an increase in the proportion of the sample retained from 60% in the control group (standard Impromy protocol), to 80% in the intervention group (modified Impromy protocol) (a = 0.05).

Statistical analysis TBA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2016
Actual
22/02/2016
Date of last participant enrolment
Anticipated
Actual
14/03/2016
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
164
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292648 0
Commercial sector/Industry
Name [1] 292648 0
Probiotec Limited
Country [1] 292648 0
Australia
Funding source category [2] 292649 0
Government body
Name [2] 292649 0
CSIRO
Country [2] 292649 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13 Kintore Ave Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291367 0
None
Name [1] 291367 0
N/A
Address [1] 291367 0
N/A
Country [1] 291367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294123 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 294123 0
Ethics committee country [1] 294123 0
Australia
Date submitted for ethics approval [1] 294123 0
20/05/2015
Approval date [1] 294123 0
18/11/2015
Ethics approval number [1] 294123 0
Proposal #05/2015 Amendment #2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62578 0
Dr Jane Bowen
Address 62578 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 62578 0
Australia
Phone 62578 0
+61 8 83038907
Fax 62578 0
Email 62578 0
[email protected]
Contact person for public queries
Name 62579 0
jane bowen
Address 62579 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 62579 0
Australia
Phone 62579 0
+61 8 83038907
Fax 62579 0
Email 62579 0
[email protected]
Contact person for scientific queries
Name 62580 0
jane bowen
Address 62580 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 62580 0
Australia
Phone 62580 0
+61 8 83038907
Fax 62580 0
Email 62580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
this was not included in the ethics application, and is a partly commercially funded trial.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized trial of a high protein, partial meal replacement program with or without alternate day fasting: Similar effects on weight loss, retention status, nutritional, metabolic, and behavioral outcomes.2018https://dx.doi.org/10.3390/nu10091145
N.B. These documents automatically identified may not have been verified by the study sponsor.