ANZCTR - Registration

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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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

The control treatment was a preload meal enriched with whey protein isolate.

Control group

Active

Outcomes

Primary outcome [1]

Subsequent intake of a hot fried rice meal and water measured using digital scales

Timepoint [1]

120 min after consumption of the preload meal.

Primary outcome [2]

Feelings of appetite as assessed using a Visual Analogue Scale

Timepoint [2]

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]

None

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Manawatu

Funding & Sponsors

Funding source category [1]

University

Name [1]

Riddet Institute, Massey University

Address [1]

Massey University
Private Bag 11-222
Palmerston North 4442

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Massey University Human Ethics Committee

Ethics committee address [1]

Research Ethics Office
Turitea Campus
Massey University
Private Bag 11-222
Palmerston North 4442

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

23/08/2011

Ethics approval number [1]

HEC: Southern A Application 11/47

Summary

Brief summary

Dairy whey protein is known for its greater satiating effect compared to carbohydrate and other protein sources. The purported satiating effect of whey protein may be due to the unique mixture of proteins in whey, to major constituent individual proteins and/or to its amino acid composition. Research investigating which component of dairy whey protein plays a role in its satiating effect is limited. In the present study, the effects of dietary whey protein given as intact whey protein isolate, beta-lactoglobulin, alpha-lactalbumin or a free amino acid mixture simulating the amino acid composition of whey protein isolate, on subsequent food intake 120 min later and subjective measures of satiety were compared in healthy normal-weight young adult women.

Trial website

Trial related presentations / publications

N/A

Public notes

Attachments [1]

/AnzctrAttachments/368246-Copy approval ethics.pdf

Contacts

Principal investigator

Name

Dr Sylvia Chungchunlam

Address

Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442

Country

New Zealand

Phone

+64210376080

Fax

sylvia.lawrence.17@gmail.com

Contact person for public queries

Name

Sylvia Chungchunlam

Address

Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442

Country

New Zealand

Phone

+64210376080

Fax

sylvia.lawrence.17@gmail.com

Contact person for scientific queries

Name

Sylvia Chungchunlam

Address

Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442

Country

New Zealand

Phone

+64210376080

Fax

sylvia.lawrence.17@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Effect of whey protein and a free amino acid mixture simulating whey protein on measures of satiety in normal-weight women.	2016	https://dx.doi.org/10.1017/S0007114516003767

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically