Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000943246
Ethics application status
Approved
Date submitted
2/11/2009
Date registered
3/11/2009
Date last updated
3/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of acute and longer-term energy restriction in lean and obese subjects on gut motility, hormones, appetite and energy intake in response to small intestinal nutrients and on oral fat perception
Scientific title
Effects of acute and longer-term energy restriction in lean and obese subjects on antropyloroduodenal motility, gut hormones, appetite and energy intake in response to duodenal nutrients and on oral fat perception
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Investigate the effects of acute (4 days) energy restriction on gastrointestinal (GI) function and appetite, in both lean and obese subjects. 252095 0
Investigate the effects of prolonged (3 months) energy restriction on GI function, appetite and weight loss in obese subjects,
in response to duodenal nutrients. 252100 0
Condition category
Condition code
Diet and Nutrition 252302 252302 0 0
Obesity
Oral and Gastrointestinal 252306 252306 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Obese subjects will undergo a 12-week period of dietary restriction which will entail a 30% reduction of total energy intake, using a macronutrient-balanced (15% protein, 55% carbohydrate, 30% fat) diet. A standard 6000, 7000kJ and 8000kJ dietary intake using Lite and Easy menu structure will be utilised. Lean individuals will only be studied during a 4-day period of dietary restriction. During this time subjects will be given a complete meal plan to follow on a day-to-day basis and a meal check list to ensure they comply with the diet. The meal plan will contain a variety of foods for the subject to consume to ensure a varied diet. Compliance with the diet will be checked regularly throughout the study by a dietician, and subjects will be provided with all study food, including all meals and snacks, to facilitate adherence to the diet. Obese subjects will attend the laboratory on 4 days and lean subjects will attend on 2 days, to evaluate the effects of the dietary manipulations on GI motility, hormone release, appetite and energy intake in response to intraduodenl infusion of fat (Intralipid) at a rate of 2.86 kcal/min for 120 min. At the end of each study day, oral fatty acid taste thresholds will also be determined in each individual.
Intervention code [1] 241487 0
Lifestyle
Comparator / control treatment
Lean individuals
Control group
Active

Outcomes
Primary outcome [1] 253174 0
Antropyloroduodenal motility -
During the 120 minute infusion antropyloduodenal motility will be assessed via changes in the pressures within the antrum, pylorus and duodenum which are captured by sensors on the catheter, and connected to a computer-based system, running commercially available hardware (Flexisoft)
Timepoint [1] 253174 0
At -15, 0, 15, 30, 45, 60, 75, 90, 120 min during the infusion period on each study day.
Study days for:
Obese - days 1 and 4 and weeks 4 and 12
Lean - days 1 and 4
Secondary outcome [1] 262094 0
Hormone release -
Cholecystokinin (CCK) and Peptide YY (PYY). Blood samples were drawn from subjects every 15 minutes until t=120, and then once more at t=150. Radioimmuno assays were used to determine the concentration of these hormones in plasma.
Timepoint [1] 262094 0
At -15, 0, 15, 30, 45, 60, 75, 90, 120 and 150 min during the infusion period on each study day.
Study days for:
Obese - days 1 and 4 and weeks 4 and 12
Lean - days 1 and 4
Secondary outcome [2] 262095 0
Energy intake-
At t = 120 min the infusion will be discontinued, and the subject extubated and offered a cold buffet-style meal (t = 120 - 150 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork
Timepoint [2] 262095 0
At 120 min after the infusion period on each study day.
Study days for:
Obese - days 1 and 4 and weeks 4 and 12
Lean - days 1 and 4
Secondary outcome [3] 262096 0
Oral fatty acid taste thresholds -
Taste thresholds were determined by 3 ascending forced choice procedure
Timepoint [3] 262096 0
At 210 min one hour after comsumption of the buffet meal on each study day.
Study days for:
Obese - days 1 and 4 and weeks 4 and 12
Lean - days 1 and 4

Eligibility
Key inclusion criteria
Subjects will all be males between age 18 -55 years, with a body mass index (BMI) of 18 - 25 kg/m2 for lean and between 30 -35 kg/m2 for obese. Lean subjects will be required to be unrestrained eaters, consume less than 20g of alcohol per week, be non-smokers, free of gastrointestinal or chronic disease and not currently taking medication.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each subject will be questioned prior to the study to exclude:
(1)significant gastrointestinal symptoms; disease or surgery
(2)current use of medications which may alter gastrointestinal motor function or appetite
(3)diabetes mellitus (fasting glucose >6.9 mmol/l and/or glycated haemoglobin =6.2 %)
(4)epilepsy
(5)cardiovascular or respiratory disease
(6)any other significant illness as assessed by the investigator
(7)allergy to local anaesthetic
(8)intake of > 20 g alcohol on a daily basis
(9)smokers
(10)individuals with food intolerances, allergies or vegetarians

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited via newspaper advertisement or flyers which were posted in the local paper (Adelaide Advertiser), displayed within the University of Adelaide and the Royal Adelaide Hospital. Concealment allocation was not used in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243959 0
Self funded/Unfunded
Name [1] 243959 0
A/Prof Christine Feinle-Bisset
Country [1] 243959 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christine Feinle-Bisset
Address
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 251309 0
Individual
Name [1] 251309 0
Prof Peter Clifton
Address [1] 251309 0
Food and Nutritional Sciences Gate 13, Kintore Avenue Adelaide SA 5000
Country [1] 251309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244066 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 244066 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 244066 0
Australia
Date submitted for ethics approval [1] 244066 0
23/09/2009
Approval date [1] 244066 0
23/10/2009
Ethics approval number [1] 244066 0
090816a

Summary
Brief summary
To investigate the effects of:
(1) acute (4 days) energy restriction on GI function and appetite, in both lean and obese subjects,
(2) prolonged (3 months) energy restriction on GI function, appetite and weight loss in obese subjects,
in response to duodenal nutrients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30448 0
Address 30448 0
Country 30448 0
Phone 30448 0
Fax 30448 0
Email 30448 0
Contact person for public queries
Name 13695 0
Radhika Seimon
Address 13695 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 13695 0
Australia
Phone 13695 0
+61 8 8222 5039
Fax 13695 0
+61 8 8223 3870
Email 13695 0
[email protected]
Contact person for scientific queries
Name 4623 0
Radhika Seimon
Address 4623 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 4623 0
Australia
Phone 4623 0
+61 8 8222 5039
Fax 4623 0
+61 8 8223 3870
Email 4623 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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