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Trial registered on ANZCTR


Registration number
ACTRN12620000658910
Ethics application status
Approved
Date submitted
10/05/2020
Date registered
9/06/2020
Date last updated
9/06/2020
Date data sharing statement initially provided
9/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of dietary proteins with different rates of digestion and absorption on food intake and subjective feelings of appetite, and circulating blood amino acids in normal-weight young adult men
Scientific title
The effects of dietary proteins with different rates of digestion and absorption on food intake and subjective ratings of appetite, and circulating plasma amino acids in normal-weight young adult men
Secondary ID [1] 301244 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight loss and management 317412 0
Protein metabolism 317569 0
Condition category
Condition code
Diet and Nutrition 315514 315514 0 0
Obesity
Metabolic and Endocrine 315516 315516 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design of the study is a randomised single-blind cross-over design. Each male participant participated in 5 sessions in total with a minimum of at least 2 days between each session. On each study day, participants arrived in the morning after fasting for about 10 hours. Upon arrival at the laboratory (Human Nutrition Research Unit), an intravenous cannula was placed in a vein of the subject's arm to allow for drawing of multiple blood samples. After the initial fasting blood draw (baseline), the subject filled out his first set of Visual Analogue Scales (VAS) questionnaire to assess his feelings of appetite and well-being. The subject was given his preload meal (enriched tomato soup, plain biscuits and 100 ml of water) to consume within 15 min. Consumption of the preload meal was directly supervised, namely the amount of the preload meal ingested and the time it took to consume all of the preload meal were recorded. After complete ingestion of the preload meal (time 0), a questionnaire for the palatability of the preload meal and a VAS questionnaire is completed. The VAS questionnaire was completed at 30, 60, 90, 120, 150, 180, 240, 300, and 360 min. Blood (10 ml each) was collected at 60, 120, 180, 240, 300, and 360 min. At 120 and 240 min, 250 ml of water was given to the participants to keep them hydrated. After completing the 360 min blood draw and VAS questionnaire, the cannula was removed and subjects were provided with a hot meal and water to consume until satisfied within 15 min. The participant was asked to fill in a questionnaire asking about the overall likeability of the hot meal of fried rice at that time, and a VAS questionnaire 15 and 30 min following complete consumption of the hot meal. The participant was then able to leave the laboratory.

The time involvement for each subject on each study day was at least 7 hours (420 min) and there are 5 study days, therefore 35 hours.

The preload test meals consisted of 450 ml of one of the five tomato soups, 150 g of protein-free plain biscuits, and 100 ml of water. 400 ml of tomato soups were reconstituted in hot water (57 g/L) and cooled down before adding either 49 g of maltodextrin, a carbohydrate with a simple structure, or 48.9 g of whey protein isolate, or 48.6 g of alpha-lactabumin, a constituent of whey protein, or 54.4 g of casein, or 49.1 g of zein, a protein derived from maize. All the ingredients in the preload drinks are natural food-grade materials normally consumed in foods. The four protein preload test meals were balanced to provide 45 g of crude protein on a dry matter basis, and 45 g of available carbohydrate on a dry matter basis was provided in the maltodextrin carbohydrate preload test meal.
Intervention code [1] 317544 0
Treatment: Other
Comparator / control treatment
The control treatment was a preload test meal enriched with maltodextrin carbohydrate.
Control group
Active

Outcomes
Primary outcome [1] 323757 0
Intake of a hot meal of fried rice and water measured using digital scales
Timepoint [1] 323757 0
360 min following complete consumption of the preload test meal
Primary outcome [2] 323758 0
This is a composite outcome as subjective feelings of appetite (hunger, desire to eat, prospective food consumption and fullness) and well-being (nausea and thirst) are related and rated using 10 cm Visual Analogue Scales (VAS) on the same questionnaire
Timepoint [2] 323758 0
This time course study had several primary time points. Baseline upon arrival at the laboratory and 0 (immediately after consumption of the preload test meal), 30, 60, 90, 120, 150, 180, 240, 300, and 360 min after complete ingestion of the preload test meal were used as the 11 primary time points.
Primary outcome [3] 323759 0
Circulating plasma levels of amino acids
Timepoint [3] 323759 0
This time course study had several primary time points. Baseline upon arrival at the laboratory and 60, 120, 180, 240, 300, and 360 min after complete ingestion of the preload test meal were used as the 7 primary time points.
Secondary outcome [1] 382794 0
The overall rated palatability of the preload test meal is a composite outcome as the overall likeability, pleasantness of taste, and likeability of texture of the preload test meal measured using 10 cm Visual Analogue Scales (VAS) questionnaires were related.
Timepoint [1] 382794 0
immediately after complete consumption of the preload test meal
Secondary outcome [2] 382795 0
Ratings of overall likeability of fried rice test meal using 10 cm Visual Analogue Scales (VAS) questionnaires
Timepoint [2] 382795 0
immediately after complete consumption of the fried rice test meal
Secondary outcome [3] 383235 0
circulating plasma glucose
Timepoint [3] 383235 0
This time course study used baseline upon arrival at the laboratory, 60, 120, 180, 240, 300, and 360 min after complete ingestion of the preload test meal.

Eligibility
Key inclusion criteria
Men aged 18-40 years, within a body mass index (BMI) of 18-26 kg/m2 and in good general health.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included smoking or recreational drug user, consumption of more than 2 standard units of alcohol per day, athletic training of more than 7 h per week, anaemic or a bleeding or clotting disorder or blood borne disease and/or taking medication that may affect blood clotting, a gastrointestinal disorder and/or diet-related illness, on a body weight loss or gain programme and/or have or being treated for any eating disorders, skip meals or having restrained eating habits, taking medication or supplements that may affect body weight, appetite, or gut function, vegetarian/vegan, an aversion to having blood samples taken. Participants who had an intolerance or disliking regarding the test foods, particularly milk, milk-derivatives, maize-derived products or proteins, 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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 study by Anderson et al. 2004, indicated that a sample size of sixteen male participants had sufficient power of 80% at a level of significance of 0.05 to allow the detection of differences in subsequent test meal intake. In the Anderson et al. 2004 study, the maximum effect size in subsequent energy intake was shown to be 1050 kJ (27.5% lower with whey protein compared to egg albumen) and the standard deviation was estimated to be 904 kJ.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2017
Date of last participant enrolment
Anticipated
Actual
26/10/2018
Date of last data collection
Anticipated
Actual
20/12/2018
Sample size
Target
16
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 22548 0
New Zealand
State/province [1] 22548 0
Manawatu

Funding & Sponsors
Funding source category [1] 305692 0
University
Name [1] 305692 0
Riddet Institute, Massey University
Country [1] 305692 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute, Massey University
Address
Massey University
Private Bag 11-222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 306105 0
None
Name [1] 306105 0
Address [1] 306105 0
Country [1] 306105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305970 0
Massey University Human Ethics Committee
Ethics committee address [1] 305970 0
Ethics committee country [1] 305970 0
New Zealand
Date submitted for ethics approval [1] 305970 0
12/07/2017
Approval date [1] 305970 0
08/09/2017
Ethics approval number [1] 305970 0
HEC: Southern A Application 17/39

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

Contacts
Principal investigator
Name 102254 0
Dr Sylvia Chungchunlam
Address 102254 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 102254 0
New Zealand
Phone 102254 0
+64210376080
Fax 102254 0
Email 102254 0
sylvia.lawrence.17@gmail.com
Contact person for public queries
Name 102255 0
Sylvia Chungchunlam
Address 102255 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 102255 0
New Zealand
Phone 102255 0
+64210376080
Fax 102255 0
Email 102255 0
sylvia.lawrence.17@gmail.com
Contact person for scientific queries
Name 102256 0
Sylvia Chungchunlam
Address 102256 0
Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
Country 102256 0
New Zealand
Phone 102256 0
+64210376080
Fax 102256 0
Email 102256 0
sylvia.lawrence.17@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In reference to human ethical approval, all individual participant data will be accessible to the research team only so as to maintain confidentiality of identities.


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
EmbaseEffects of the maize-derived protein zein, and the milk proteins casein, whey, and alpha-lactalbumin, on subjective measures of satiety and food intake in normal-weight young men.2023https://dx.doi.org/10.1016/j.appet.2022.106339
N.B. These documents automatically identified may not have been verified by the study sponsor.