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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
Date results information 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
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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
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Secondary ID [1]
301244
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Weight loss and management
317412
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Protein metabolism
317569
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Condition category
Condition code
Diet and Nutrition
315514
315514
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0
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Obesity
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Metabolic and Endocrine
315516
315516
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317544
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Treatment: Other
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Comparator / control treatment
The control treatment was a preload test meal enriched with maltodextrin carbohydrate.
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Control group
Active
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Outcomes
Primary outcome [1]
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Intake of a hot meal of fried rice and water measured using digital scales
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Assessment method [1]
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Timepoint [1]
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360 min following complete consumption of the preload test meal
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Primary outcome [2]
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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
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Assessment method [2]
323758
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Timepoint [2]
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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.
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Primary outcome [3]
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Circulating plasma levels of amino acids
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Assessment method [3]
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Timepoint [3]
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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.
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Secondary outcome [1]
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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.
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Assessment method [1]
382794
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Timepoint [1]
382794
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immediately after complete consumption of the preload test meal
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Secondary outcome [2]
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Ratings of overall likeability of fried rice test meal using 10 cm Visual Analogue Scales (VAS) questionnaires
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Assessment method [2]
382795
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Timepoint [2]
382795
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immediately after complete consumption of the fried rice test meal
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Secondary outcome [3]
383235
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circulating plasma glucose
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Assessment method [3]
383235
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Timepoint [3]
383235
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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.
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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.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/09/2017
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Date of last participant enrolment
Anticipated
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Actual
26/10/2018
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Date of last data collection
Anticipated
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Actual
20/12/2018
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Sample size
Target
16
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Accrual to date
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Final
13
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Recruitment outside Australia
Country [1]
22548
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New Zealand
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State/province [1]
22548
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Manawatu
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Funding & Sponsors
Funding source category [1]
305692
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University
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Name [1]
305692
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Riddet Institute, Massey University
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Address [1]
305692
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Massey University
Private Bag 11-222
Palmerston North 4442
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Country [1]
305692
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New Zealand
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Primary sponsor type
University
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Name
Riddet Institute, Massey University
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Address
Massey University
Private Bag 11-222
Palmerston North 4442
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Country
New Zealand
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Secondary sponsor category [1]
306105
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None
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Name [1]
306105
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Address [1]
306105
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Country [1]
306105
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305970
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Massey University Human Ethics Committee
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Ethics committee address [1]
305970
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Research Ethics Office
Turitea Campus
Massey University
Private Bag 11-222
Palmerston North 4442
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Ethics committee country [1]
305970
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New Zealand
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Date submitted for ethics approval [1]
305970
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12/07/2017
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Approval date [1]
305970
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08/09/2017
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Ethics approval number [1]
305970
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HEC: Southern A Application 17/39
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Summary
Brief summary
It is widely accepted that consumption of protein is more satiating than carbohydrate or fat (lower food intake at a subsequent meal and lower subjective ratings of appetite), but the satiating effect of protein is thought to be source dependent. As the speed at which proteins are digested in the stomach and the building blocks of proteins, amino acids, are absorbed in the small intestine, differ among proteins, proteins have been grouped into either “fast” proteins, which are rapidly digested, or “slow” proteins, which form clots in the stomach and are therefore slowly digested and absorbed. In this study, the effects of two "slow" proteins (zein, a protein originating from maize, and casein, a dairy milk protein), two "fast" dairy milk proteins (whey protein and alpha-lactabumin), and a carbohydrate (maltodextrin, a simple carbohydrate) control on subsequent food intake at a test meal, subjective measures of satiety, and circulating amino acid responses were compared in healthy normal-weight young adult men. We hypothesise that all four proteins will elicit stronger satiety and plasma amino acid responses compared with the maltodextrin carbohydrate control, with "slow" proteins being more satiating and having a more delayed plasma amino acid response, than "fast" proteins.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sylvia Chungchunlam
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Address
102254
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Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
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Country
102254
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New Zealand
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Phone
102254
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+64210376080
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Fax
102254
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Email
102254
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[email protected]
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Contact person for public queries
Name
102255
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Dr Sylvia Chungchunlam
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Address
102255
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Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
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Country
102255
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New Zealand
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Phone
102255
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+64210376080
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Fax
102255
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Email
102255
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[email protected]
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Contact person for scientific queries
Name
102256
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Dr Sylvia Chungchunlam
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Address
102256
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Riddet Institute
Massey University
Private Bag 11-222
Palmerston North 4442
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Country
102256
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New Zealand
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Phone
102256
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+64210376080
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Fax
102256
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Email
102256
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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
Effects 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.
2023
https://dx.doi.org/10.1016/j.appet.2022.106339
N.B. These documents automatically identified may not have been verified by the study sponsor.
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