Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000562673
Ethics application status
Approved
Date submitted
21/05/2014
Date registered
27/05/2014
Date last updated
27/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a high protein preload drink on satiety, food intake, satiety-related hormones and protein metabolites.
Scientific title
The effect of a high protein preload drink on satiety, food intake, satiety-related hormones and protein metabolites in healthy normal-weight young adult women.
Secondary ID [1] 284635 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 291950 0
Condition category
Condition code
Diet and Nutrition 292300 292300 0 0
Obesity
Metabolic and Endocrine 292333 292333 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant participated in 3 sessions in total with a minimum of 2 days between each session. Two flavoured milk-based preload drinks differing in carbohydrate and protein were administered 120 min before an ad libitum test meal. A water control was also administered.

Each subject was provided with a standardised breakfast to consume 3 h before coming to the laboratory and only water is permitted thereafter. Upon arrival at the laboratory, a cannula was placed into a vein in the subject's arm for repeated blood draws. Subject was given a preload drink to consume within 5 min. Subjects completed some questionnaires to assess their feelings of appetite and had 8 blood samples (10 ml each) collected within 120 min. At the end of the 120 min, the cannula was removed and subjects were provided with a hot meal and water to consume until satisfied within 15 min.

The time involvement for each subject on each session day was at least 170 min and there are 3 sessions, therefore 510 min.

The 300 ml preload drinks used a sweet flavoured milky solution as a base to which 45 g of either maltodextrin, a carbohydrate with a simple structure or cheese whey protein isolate will be added. All the ingredients in the preload drinks are natural food-grade materials normally consumed in foods. The amount of carbohydrate and protein in 300 ml of the carbohydrate-enriched preload drink was 72 g and 3 g, respectively. The whey protein-enriched preload drink contributed 26 g carbohydrate and 46 g protein per 300 ml drink.

Intervention code [1] 289421 0
Behaviour
Intervention code [2] 289422 0
Treatment: Other
Comparator / control treatment
The control treatment was a water (no energy) preload drink.
Control group
Placebo

Outcomes
Primary outcome [1] 292170 0
Subsequent food intake of a hot meal measured using digital scales
Timepoint [1] 292170 0
120 min after ingestion of the preload drink.
Primary outcome [2] 292171 0
Feelings of appetite as assessed using a Visual Analogue Scale
Timepoint [2] 292171 0
baseline, immediately after consumption of the preload drink, 15, 30, 45, 60, 75, 90 and 120 min after finishing the preload drink and 15 and 30 min after consumption of the hot meal.
Primary outcome [3] 292172 0
Circulating plasma levels of satiety-related hormones (glucose, insulin, ghrelin, CCK, GIP, GLP-1, PP and PYY) and protein metabolites (amino acids, urea and ammonia)
Timepoint [3] 292172 0
baseline, immediately after consumption of the preload drink, and 15, 30, 45, 60, 75, 90 and 120 min after finishing the preload drink
Secondary outcome [1] 308356 0
None
Timepoint [1] 308356 0
None

Eligibility
Key inclusion criteria
Women aged 18-40, within a BMI of 19-30 kg/m2 and in good general health.

Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Training athlete, smoker or recreational drug user, vegeratian or vegan, anaemic or suffering from a bleeding or clotting disorder and/or taking medication that affects blood clotting, having a diet-related illness, pregnant or breast-feeding or having a history of menstrual irregularities, an allergy or intolerance to milk or milk-derived products, an aversion to having blood samples taken.

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)
The principal investigator, Dr Sylvia Chungchunlam, carried out the screening process to ensure that potential participants met the selection criteria.

Subjects were their own control and each treatment was allocated using random numbers in Microsoft Excel. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
31/03/2009
Actual
20/04/2009
Date of last participant enrolment
Anticipated
Actual
15/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 6064 0
New Zealand
State/province [1] 6064 0
Manawatu

Funding & Sponsors
Funding source category [1] 289261 0
University
Name [1] 289261 0
Riddet Institute, Massey University
Country [1] 289261 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute
Address
Massey University
Private Bag 11-222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 287935 0
None
Name [1] 287935 0
Address [1] 287935 0
Country [1] 287935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291034 0
Massey University Human Ethics Committee
Ethics committee address [1] 291034 0
Ethics committee country [1] 291034 0
New Zealand
Date submitted for ethics approval [1] 291034 0
Approval date [1] 291034 0
08/07/2008
Ethics approval number [1] 291034 0
HEC: Southern A Application 08/38

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

Contacts
Principal investigator
Name 48558 0
Dr Sylvia Chungchunlam
Address 48558 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 48558 0
New Zealand
Phone 48558 0
+64210376080
Fax 48558 0
Email 48558 0
[email protected]
Contact person for public queries
Name 48559 0
Sylvia Chungchunlam
Address 48559 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 48559 0
New Zealand
Phone 48559 0
+64210376080
Fax 48559 0
Email 48559 0
[email protected]
Contact person for scientific queries
Name 48560 0
Sylvia Chungchunlam
Address 48560 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 48560 0
New Zealand
Phone 48560 0
+64210376080
Fax 48560 0
Email 48560 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
SourceTitleYear of PublicationDOI
Dimensions AIDietary whey protein influences plasma satiety-related hormones and plasma amino acids in normal-weight adult women2015https://doi.org/10.1038/ejcn.2014.266
N.B. These documents automatically identified may not have been verified by the study sponsor.