Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000112066
Ethics application status
Approved
Date submitted
29/01/2010
Date registered
3/02/2010
Date last updated
3/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
High- versus low-energy density preloads in overweight/obese men: acute effects on gastric emptying, gut hormone release and energy expenditure
Scientific title
High- versus low-energy density preloads in overweight/obese men: acute effects on gastric emptying, gut hormone release and thermogenesis
Secondary ID [1] 1354 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To determine the acute effect of manipulating the energy density of a meal by increasing its fat content, on subsequent energy intake at lunch, in obese men. 256710 0
To determine whether the effect of energy density is related to changes in mediators of energy intake including gastric emptying, gut hormone release, postprandial thermogenesis and appetite sensations. 256727 0
Condition category
Condition code
Oral and Gastrointestinal 256867 256867 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental design - The study will utilise a single-blind, randomized cross-over design and measure gastric emptying, gut hormone release, diet-induced thermogenesis, appetite perceptions, and subsequent energy intake in response to three oral preloads: 1. High energy density (HED) 2. Low energy density, high fat (LedHF); and, 3. Low energy density, high protein (LedHP). Details of the preloads are described below.

Preloads - The energy densities and macronutrient compositions of the 3 semi-solid test preloads are: 1. High energy density (HED; 1.48 kcal/g; 999 kcal; g fat/protein is 62/30); 2. Low energy density, high fat (LedHF; 1.15 kcal/g; 777 kcal; g fat/protein is 37/29); and, 3. Low energy density, high protein (LedHP; 1.15 kcal/g; 777 kcal; g fat/protein is 22/63). All preloads will be matched for grams of carbohydrate, volume (673 g), palatability, smell, texture and look. The total energy of all preloads will represent between ~30% of estimated daily energy requirement for overweight men. All preloads will comprise of varying quantities of milk, natural yoghurt, frozen raspberries, cream, water, sugar, cornflour and gelatine. Each will also contain 5 ml of egg yolk that is labeled with 75 kBq of Octanoic acid sodium salt [1 – 14C] for the assessment of gastric emptying rate. In addition, whey protein isolate and cream will be used to manipulate the protein and fat contents of the preloads.

Experimental protocol - On 3 occasions, each separated by 3-7 days, subjects will have their fasting and postprandial energy expenditure, appetite profile, gastric emptying, gut hormone release and subsequent energy intake measured. Fasting energy expenditure will be determined by indirect calorimetry using a clear plastic ventilated hood and the TrueOne metabolic monitor while subjects lay in the supine position at rest (no fidgeting or talking allowed) for 40 minutes from 0800h. The amount of oxygen consumed and carbondioxide (CO2) produced in the breath is used to measure the amount of energy expended. Afterwards, a cannula will be inserted into a forearm vein to collect blood. In addition, a baseline sample of their breath will be collected for the assessment of gastric emptying rate; for this, subjects will be asked to blow through a straw which is connected to a glass scintillation vial that contains 0.5 mmol of a proprietary CO2 trapping agent. The 14C-Octanoic acid breath test is a validated, indirect marker for the rate of liquid and semisolid gastric emptying. The quantity of breath 14C02 (disintegrations per min, DPM) will be measured using Liquid Scintillation Counting. The activity of 14CO2 in the breath and expressed as a percentage of the original dose ingested in the preload, at the respective time points, will be plotted against time and non-linear regression modelling of the data will be used to determine the lag time (defined as the time before any radioactivity is excreted via the breath), 50% emptying time, the amount of meal retained at 180 mins and gastric emptying coefficient. Subjects will then consume, in random order, one of the three semi-solid experimental preloads. 10 minutes will be allowed to finish the preload. Subjects will then return to the bed and rest quietly under the ventilated hood for a further 3 hrs to measure postprandial energy expenditure for the determination of diet-induced thermogenesis. Blood will be drawn for the samples for the determination of plasma concentrations of glucose, insulin, gut hormones (ghrelin, glucagon like peptide-1 (GLP-1), peptide YY (PPY), cholecystokinin (CCK). At the same time points appetite ratings (fullness, hunger, desire to eat and amount of food that could be eaten) will be recorded using validated 100-mm visual analogue scales. Breath samples to assess gastric emptying will also be collected. At the end of the 3 hours, a cold buffet-style meal will be offered to subjects and they will be asked to eat until ‘comfortably full’ over a 30 min period.
Intervention code [1] 255941 0
Lifestyle
Comparator / control treatment
HED
Control group
Dose comparison

Outcomes
Primary outcome [1] 257735 0
Gastric emptying using the 14C-Octanoic breath test. The 14C-Octanoic acid breath test is a validated, indirect marker for the rate of liquid and semisolid gastric emptying. The quantity of breath 14C02 (disintegrations per min, DPM) will be measured using Liquid Scintillation Counting
Timepoint [1] 257735 0
At -15 min and at 0, 15, 30, 45, 60, 75, 90, 105, 120, 165, 180 and 210 min after consumption of preload'.
Secondary outcome [1] 263103 0
Plasma glucose, insulin and gut hormones (ghrelin, GLP-1, CCK, PPY). Blood samples were drawn from subjects every 15 minutes until t=60, and then every 30 min from t = 60 - 180 min and then once more at t=210 min after the buffet lunch. Radioimmunoassays were used to determine the concentration of these hormones in plasma.
Timepoint [1] 263103 0
At -15 min and at 0, 15, 30, 45, 60, 90, 120, 180 and 210 min after consumption of preload'.
Secondary outcome [2] 263104 0
Fasting energy expenditure and diet-induced thermogenesis - energy expenditure will be determined by indirect calorimetry using a clear plastic ventilated hood and the TrueOne metabolic monitor while subjects lay in the supine position
Timepoint [2] 263104 0
At -15 min and every 15mins between t =0 - 180 min
Secondary outcome [3] 263105 0
Appetite ratings including hunger, fullness, thirst, desire to eat, and amount of food desired to eat using Visual Analogue Scales questionnaires
Timepoint [3] 263105 0
At -15 min and at 0, 15, 30, 45, 60, 90, 120, 180 and 210 min after consumption of preload
Secondary outcome [4] 263106 0
Energy intake - subject were offered a cold buffet-style meal (t = 180 - 210 min). The meal will be weighted before and after consumption to for the assessment of energy intake using Foodwork
Timepoint [4] 263106 0
Between t = 180 - 210 min

Eligibility
Key inclusion criteria
Subjects will all be males between age 18 -55 years, with a body mass index (BMI) of 27 -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:
-significant gastrointestinal symptoms, disease or surgery
-use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, body weight or appetite
-lactose intolerant/ other food allergy(s)
-current gallbladder or pancreatic disease
-diabetes mellitus
-epilepsy
-cardiovascular or respiratory diseases
-any other illnesses 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
-current smokers of cigarettes/cigars/marijuana
-current intake of any illicit substance
-restrained eaters (score > 12 on the three factor eating questionnaire)
-experience claustrophobia in confined spaces
-prior exposure to a dose of radiation in the past 12 months
-unable to comprehend study protocol

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
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)

Funding & Sponsors
Funding source category [1] 256433 0
Self funded/Unfunded
Name [1] 256433 0
A/Prof Christine Feinle-Bisset
Country [1] 256433 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
New Zealand
Secondary sponsor category [1] 255737 0
Individual
Name [1] 255737 0
Dr Natalie Luscombe-March
Address [1] 255737 0
Discipline of Medicine Level 6, Eleanor Harrald Building Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country [1] 255737 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258489 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258489 0
Ethics committee country [1] 258489 0
Australia
Date submitted for ethics approval [1] 258489 0
21/05/2008
Approval date [1] 258489 0
29/05/2008
Ethics approval number [1] 258489 0
080317

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

Contacts
Principal investigator
Name 30787 0
Address 30787 0
Country 30787 0
Phone 30787 0
Fax 30787 0
Email 30787 0
Contact person for public queries
Name 14034 0
Radhika Seimon
Address 14034 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 14034 0
Australia
Phone 14034 0
+61 8 8222 5039
Fax 14034 0
+61 8 8223 3870
Email 14034 0
[email protected]
Contact person for scientific queries
Name 4962 0
Radhika Seimon
Address 4962 0
Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 4962 0
Australia
Phone 4962 0
+61 8 8222 5039
Fax 4962 0
+61 8 8223 3870
Email 4962 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.