Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000083099
Ethics application status
Approved
Date submitted
20/01/2010
Date registered
22/01/2010
Date last updated
22/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of acute dietary restriction on gut motor, hormone and energy intake responses to duodenal fat in obese men
Scientific title
The effects of a four-day very low calorie diet on antropyloroduodenal motility, gastrointestinal hormone release, and appetite responses to small intestinal nutrient delivery in obese subjects
Secondary ID [1] 1318 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Investigate the effects of 4-day very low calorie diet on gastrointestinal (GI) function and appetite, in obese subjects 256621 0
Condition category
Condition code
Diet and Nutrition 256789 256789 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject attended the laboratory on two occasions, once after an overnight fast (visit 1, day 1) and again following four days of a very low calorie diet (VLCD) (visit 2, day 6). On both visits, the effects of a 120-min intraduodenal infusion of a lipid emulsion (10% Intralipid), infused at a load of 2.86 kcal/min, on antropyloroduodenal (APD) motility, plasma cholecystokinin (CCK), peptide YY (PYY) and ghrelin concentrations, appetite, and energy intake were quantified.

The four-day VLCD involved a 70% reduction of each individual’s energy intake, thus delivering 30% of their daily energy requirements. These were estimated using the Harris Benedict equation and a physical activity factor between 1.4-1.5 (indicative of light to moderate activity) based on an individual’s self-reported daily activity. To aid compliance with the VLCD, subjects were provided with a detailed individualised meal plan and the food items required for the diet period, including both liquid meal replacements (KicStart) and standard food items (sliced ham, wholemeal bread, salad items and pre-packaged frozen meals (Lean Cuisine beef lasagne/chicken stir-fry). The meal plan detailed the food items and their amount (g) to be consumed at each meal. In addition, subjects were permitted to consume an unlimited quantity of non-caloric beverages. To monitor compliance, subjects were required to document these (including brand names and quantities), as well as all the food consumed, throughout the 4-days, in a food diary. Subjects were also asked to maintain their normal physical activity over the course of the study and were contacted by phone during day 2 of the four-day diet to monitor their progress.
Intervention code [1] 255872 0
Lifestyle
Comparator / control treatment
All participants have their visit 2 results compared to their visit 1 results
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257656 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] 257656 0
At -15, 0, 15, 30, 45, 60, 75, 90, 120 min during the infusion period on each study day.
Primary outcome [2] 257657 0
Hormone release - Cholecystokinin (CCK), Peptide YY (PYY) and ghrelin. 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 [2] 257657 0
At -15, 0, 15, 30, 45, 60, 75, 90, 120 during the infusion period and 150 min on each study day
Secondary outcome [1] 262934 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 Foodworks
Timepoint [1] 262934 0
At 120 min after the infusion period on each study day

Eligibility
Key inclusion criteria
Subjects will all be males between age 18 -55 years, with a body mass index (BMI) of 30 - 35 kg/m2. Subjects will be required to 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 in the local paper (Adelaide Advertiser), or flyers which were posted 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256356 0
University
Name [1] 256356 0
University of Adelaide
Country [1] 256356 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] 251675 0
Individual
Name [1] 251675 0
Prof Michael Horowitz
Address [1] 251675 0
Discipline of Medicine Level 6, Eleanor Harrald Building Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country [1] 251675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258430 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258430 0
Royal Adelaide Hospital North Terrace Adelaide SA 5000
Ethics committee country [1] 258430 0
Australia
Date submitted for ethics approval [1] 258430 0
06/08/2008
Approval date [1] 258430 0
08/08/2008
Ethics approval number [1] 258430 0
030824e

Summary
Brief summary
This study aimed to investigate the hypothesis that following a 4-day very low calorie diet, the effects of intraduodenal nutrients on antropyloroduodenal motility, gastrointestinal hormone release and appetite in obese subjects, will be enhanced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30737 0
Address 30737 0
Country 30737 0
Phone 30737 0
Fax 30737 0
Email 30737 0
Contact person for public queries
Name 13984 0
Radhika Seimon
Address 13984 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 13984 0
Australia
Phone 13984 0
+61 8 8222 5039
Fax 13984 0
+61 8 8223 3870
Email 13984 0
[email protected]
Contact person for scientific queries
Name 4912 0
Radhika Seimon
Address 4912 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 4912 0
Australia
Phone 4912 0
+61 8 8222 5039
Fax 4912 0
+61 8 8223 3870
Email 4912 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.