Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000344594
Ethics application status
Approved
Date submitted
30/03/2015
Date registered
15/04/2015
Date last updated
15/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of dairy whey protein components and a free amino acid mixture simulating whey protein on subjective feelings of appetite and subsequent food intake in healthy normal-weight young adult women
Scientific title
The effect of dairy whey protein components and a free amino acid mixture simulating whey protein on subjective feelings of appetite and subsequent food intake in healthy normal-weight young adult women
Secondary ID [1] 286413 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 294575 0
Condition category
Condition code
Diet and Nutrition 294879 294879 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each female subject participated in four session days with a minimum of two days between test days. Each subject was provided with a subject-specific breakfast meal to consume at least 3 h before the test session appointment and only water is permitted thereafter. Upon arrival at the laboratory, a baseline questionnaire to assess feelings of appetite and nausea was completed. A test preload meal was served to be consumed within 15 min. Subjects completed some questionnaires to assess their feelings of appetite and nausea every 15 min for 90 min. A final questionnaire was collected at 120 min and subjects were then provided with a hot meal and water to consume until comfortably full within 15 min.

The time involvement for each subject on each session day was at least 180 min and there are 4 sessions, therefore 720 min.

The 4 four test preload meals consisted of an orange-flaboured marmalade spread to which was added either whey protein isolate, isolated alpha-lactalbumin, isolated beta-lactoglobulin or a mixture of free amino acids simulating the amino acid composition of whey protein. Each preload spread (250 g) was accompanied with a slice (45 g) of toasted low-protein bread and 100 ml of water. The whey protein isolate preload meal served as the control. The preload meals were isoenergetic (~1800 kJ) and contained a mixture of carbohydrate (52 g) and protein or amino acids (52 g amino acid equivalent). All the ingredients in the preload meals are food-grade materials.

The lunchtime test meal served 120 min following consumption of the preload meals comprised of a mixed homogeneous single hot fried rice test meal and bottled water. The hot fried rice test meal made in a commercial kitchen included white rice, minced chicken meat, eggs, peas, carrots, corn, chicken stock, salt, sugar, and vegetable oil. The fried rice test meal contained 36.8 g available carbohydrate, 8.5 g protein, 5.8 g fat and 1.0 g total dietary fibre per 100 g with a calculated metabolisable content of 982.2 kJ per 100 g. The amount of fried rice meal and water was measured before and after consumption using an electronic scale.



Intervention code [1] 291485 0
Behaviour
Intervention code [2] 291595 0
Prevention
Comparator / control treatment
The control treatment was a preload meal enriched with whey protein isolate.
Control group
Active

Outcomes
Primary outcome [1] 294631 0
Subsequent intake of a hot fried rice meal and water measured using digital scales
Timepoint [1] 294631 0
120 min after consumption of the preload meal.
Primary outcome [2] 294632 0
Feelings of appetite as assessed using a Visual Analogue Scale
Timepoint [2] 294632 0
baseline, immediately after consumption of the preload meal, 15, 30, 45, 60, 75, 90 and 120 min after consumption of the preload meal and 15 and 30 min after consumption of the hot test meal
Secondary outcome [1] 313766 0
None
Timepoint [1] 313766 0
none

Eligibility
Key inclusion criteria
Women aged 18-40, within a BMI of 19-26 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
Exclusion criteria included smoking or recreational drug user, athletic training, a gastrointestinal disorder or diet-related illness, dieting or taking medication known to affect appetite, not consuming breakfast every day, having a history of menstrual irregularities, pregnancy, lactation or trying to become pregnant. Participants who had an intolerance or disliking regarding the test foods, particularly milk-derived products, were not included in the study.

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, oversaw the recruitment of the participants by ensuring that potential subjects 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
Power analysis, based on the results from our own previous studies (Chungchunlam et al., 2013, 2014) using a randomised block design (Kastenbaum et al., 1970) indicated that a sample size of thirteen female subjects had sufficient power of 0.80 at a level of significance of 0.05 to allow the dectection of differences in ad libitum test meal intake.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2012
Actual
23/05/2012
Date of last participant enrolment
Anticipated
Actual
12/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment outside Australia
Country [1] 6773 0
New Zealand
State/province [1] 6773 0
Manawatu

Funding & Sponsors
Funding source category [1] 290986 0
University
Name [1] 290986 0
Riddet Institute, Massey University
Country [1] 290986 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] 289666 0
None
Name [1] 289666 0
Address [1] 289666 0
Country [1] 289666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292575 0
Massey University Human Ethics Committee
Ethics committee address [1] 292575 0
Ethics committee country [1] 292575 0
New Zealand
Date submitted for ethics approval [1] 292575 0
Approval date [1] 292575 0
23/08/2011
Ethics approval number [1] 292575 0
HEC: Southern A Application 11/47

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 376 376 0 0
/AnzctrAttachments/368246-Copy approval ethics.pdf

Contacts
Principal investigator
Name 56042 0
Dr Sylvia Chungchunlam
Address 56042 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 56042 0
New Zealand
Phone 56042 0
+64210376080
Fax 56042 0
Email 56042 0
[email protected]
Contact person for public queries
Name 56043 0
Sylvia Chungchunlam
Address 56043 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 56043 0
New Zealand
Phone 56043 0
+64210376080
Fax 56043 0
Email 56043 0
[email protected]
Contact person for scientific queries
Name 56044 0
Sylvia Chungchunlam
Address 56044 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 56044 0
New Zealand
Phone 56044 0
+64210376080
Fax 56044 0
Email 56044 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
EmbaseEffect of whey protein and a free amino acid mixture simulating whey protein on measures of satiety in normal-weight women.2016https://dx.doi.org/10.1017/S0007114516003767
N.B. These documents automatically identified may not have been verified by the study sponsor.