Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000941965
Ethics application status
Approved
Date submitted
31/08/2011
Date registered
1/09/2011
Date last updated
8/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of high-protein and high-fat oral preloads on thermogenesis, apetite perceptions and energy intake, and the relationship with gastrointestinal motility, gastric emptying and gut hormone release, in overweight men.
Scientific title
Acute effects of high-protein and high-fat oral preloads on thermogenesis, appetite perceptions and energy intake, and the relationship with antropyloroduodenal motility, gastric emptying and gut hormone release, in overweight men.
Secondary ID [1] 262947 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 270672 0
Condition category
Condition code
Diet and Nutrition 270847 270847 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 semi-solid preloads with the following compositions will be tested: 1. Control (low energy, % energy as protein/carbohydrate/fat is 12/32/54); 2. High-protein (HP) 55/30/15); and 3. high-fat (HF) (15/30/55). Whey protein and cream will be used for HP and HF preloads, respectively.

Study 1:
Fasting and posprandial energy expenditure, appetite profile, gastric emptying , gut hormone release and subsequent energy intake will be measured.

Fasting and postprandial energy expenditure will be measured by indirect calorimetry using a clear plastic ventilated hood and the TrueOne metabolic monitor.

Appetite profile will be measured using a Visual Analogue Scale (VAS) and gut hormones by blood samples.

Gastric emptying will be measured indirectly using 20mg/kg paracetamol dissolved in 100mL of preprepared low-joule lemon cordial.

Energy intake will be assesed by weighing food presented to the volunteer before and after consumption. The buffet meal will consists of 300ml Orange Juice, 600ml water, 375ml iced coffee, 4 slices white bread, 4 slices brown bread, 100g deli leg ham, 100g virginian chicken, 4 slices cheese, 100g lettuce, 100g cucumber, 100g tomato, 2 portions mayonnaise, 2 portions margarine, 1 medium apples, 1 medium banana, 200g chocolate custard, 150g fruit salad, and 200g strawberry yoghurt. The volunteer will be given 30 minutes to eat until he/she is comfortably full.

The volunteer will recieve one of the three preloads on each of the three study days. Each study day will be seperated by approximately one week.

Study 2:

Antropyloroduodenal activity will be assessed using a 3.5mm wide manometric catheter. The catheter will be inserted through an anaethetised nostril and allowed to pass by peristalsis through the pylorus into the duodenum. Antropyloroduodenal pressures will be continously recorded and the number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure waves will be calculated.

Volunteers will be enrolled in study 1 and if they wish, they can also participate in study 2 however, study 2 is not compulsory.

Both studies are a cross over design. Each participant in each study will consume of the three preloads, in random order.
Intervention code [1] 269290 0
Treatment: Other
Intervention code [2] 269291 0
Lifestyle
Comparator / control treatment
Control: Low-Energy preload.
Control group
Active

Outcomes
Primary outcome [1] 279541 0
Thermogenesis
Timepoint [1] 279541 0
Thermogenesis will be determined by indirect calorimetry using a clear plastic ventilated hood and the TrueOne metabolic monitor for 40 minutes from 0800h and then for 3 hrs after the consumption of the experimental preload.
Primary outcome [2] 279542 0
Macronutrient and total energy intake at the buffet meal.
Timepoint [2] 279542 0
The buffet meal will be presented at t=180 minutes, and the subject will be allowed to freely consume food until confortably full for 30 minutes until t=210. Macronutrient and total energy intake will be analysed using the FoodWorks software program.
Secondary outcome [1] 287870 0
Antropyloroduodenal motility
Timepoint [1] 287870 0
Using a manometri assembly and catheter, Antropyloroduodenal pressures will be continously monitored after the consumption of the preload from t=-15 until t=180 min.

Eligibility
Key inclusion criteria
16 overweight/obese (BMI 27-35kg/m2) subjects will be recruited. All subjects will be required to be weight-stable (i.e. <5% fluctuation in their body weight) at study entry. Subjects will be requried to maintain their normal physical activity over the course of the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Significant gastrointestinal symptoms, disease or surgery, use pf prescription or non-prescription medications (including vitamins and herbal suppliments) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg. domperidone and cisapride, anticholinergic drugs (ag. atropine), metoclopramide, erythromycin, hyoscine, orlistat, geren tea extracts, Astragalus, St Johns Wort etc), intolerance /allergy to paracetamol, current gallbladder or pancreatic disease, diabetes mellitus, epilepsy, cardiovascular or respiratory disease, any other illness as assessed by the investigator (including chronic illnesses not explicitly listed above), high performance athletes, current intake of >2 standard drinks on >5 days per week, curent smokers of cigarettes/cigars/marijuana, current intake of any illicit substances, restrained eaters (score > 12 on the three factor eating questionnaire), experience claustrophobis in confined spaces, or unable to comprehend the study protocol.

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)
Subjects will undergo a screening visit at which they will complete questionnaures to assess their suitability for the study, and also provide informed, written, consent. If the subject is eligible, study dates will be established. Eligible volunteers are randomised into a treatment for each study visit using a randomisation table created in an excel spreadsheet.

The person who determined if a subject was eligible for inclusion into the trial was unaware, when this decision was made, to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation table was generated using Microsoft Office Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4424 0
5000
Recruitment postcode(s) [2] 4428 0
5002
Recruitment postcode(s) [3] 4431 0
5008
Recruitment postcode(s) [4] 4429 0
5009
Recruitment postcode(s) [5] 4432 0
5027
Recruitment postcode(s) [6] 4426 0
5036
Recruitment postcode(s) [7] 4425 0
5037
Recruitment postcode(s) [8] 4430 0
5043
Recruitment postcode(s) [9] 4427 0
5061

Funding & Sponsors
Funding source category [1] 269770 0
Government body
Name [1] 269770 0
National Health and Medical Research Counsil Grant
Country [1] 269770 0
Australia
Primary sponsor type
Individual
Name
Professor Christine Feinle-Bisset
Address
Level 6, Eleanor Harrald Building Frome road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 268810 0
Individual
Name [1] 268810 0
Dr Natalie Luscombe-Marsh
Address [1] 268810 0
Level 6, Eleanor Harrald Building Frome road
Adelaide SA 5000
Country [1] 268810 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271730 0
Royal Adelaide Ethics Committee
Ethics committee address [1] 271730 0
Level 3, Hanson Institute North Tce,
Adelaide, SA 5000
Ethics committee country [1] 271730 0
Australia
Date submitted for ethics approval [1] 271730 0
19/02/2008
Approval date [1] 271730 0
29/05/2008
Ethics approval number [1] 271730 0
080317

Summary
Brief summary
This study has been designed to investigate how a high-protein or high-fat preload effect thermogenesis, antropyloroduodenal motility, gut hormones, gastric emptying and appetie.

Volunteers are required to visit the department on 3 occasions (6 if they wish to take part in Study 2 as well) approximately 7 days apart. They will be required to injest one of the three preloads on each occassions, and lie supine under a calorimetry hood. Venous blood samples will be taken at set intervals and appetite questionnaire will be answered after a blood sample has been collected. A buffet meal will be presented at 180min and consumed over 30 minutes until comfortably full.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33088 0
Address 33088 0
Country 33088 0
Phone 33088 0
Fax 33088 0
Email 33088 0
Contact person for public queries
Name 16335 0
Dr Natalie Luscombe-Marsh
Address 16335 0
level 6, Eleanor Harrald Building
Frome Road
Adelaide, SA 5000
Country 16335 0
Australia
Phone 16335 0
+61 08 8222 5038
Fax 16335 0
Email 16335 0
natalie.luscombe@adelaide.edu.au
Contact person for scientific queries
Name 7263 0
Dr Natalie Luscombe-Marsh
Address 7263 0
level 6, Eleanor Harrald Building
Frome Road
Adelaide, SA 5000
Country 7263 0
Australia
Phone 7263 0
+61 08 8222 5038
Fax 7263 0
Email 7263 0
natalie.luscombe@adelaide.edu.au

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

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