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Trial registered on ANZCTR


Registration number
ACTRN12619000852156
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Date results information initially provided
17/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Digestibility of High-Protein Drinks in Seniors
Scientific title
Evaluating post-ingestion amino acid release and metabolism of high protein drinks in healthy adults aged 50-70 years
Secondary ID [1] 297133 0
None
Universal Trial Number (UTN)
U1111-1219-5047
Trial acronym
MultiProMo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal muscle loss with aging 311135 0
Condition category
Condition code
Diet and Nutrition 309762 309762 0 0
Other diet and nutrition disorders
Musculoskeletal 310655 310655 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Cross-over nutrition study to evaluate post-ingestion amino acid release and metabolism of two high-protein drinks with a comparator drink.


Intervention

The drinks to be evaluated, including comparator drink, are high-protein drinks made from plant and animal food proteins routinely used in food products, containing 11.2% protein, 5% fat and 12% carbohydrate. Participants consume 250-275 ml of drink.

Participants consume a provided meal before 10 pm the night before the session, remaining in a fasted state after the evening meal and take a urine sample on rising. On arrival at the research unit (7.30-9.00 am) they are cannulated in an elbow or forearm vein, and consume one of the high-protein drinks. They receive 250 ml water every hour. Blood samples are collected at intervals for plasma amino acid and metabolomics analysis. Participants provide urine at intervals for urine metabolomics analysis. Participants regularly rate satiety and thirst.

Those designing the trial and the participant contact have completed the Massey University training module on ethical conduct and standards for Human and Animal studies. Cannulation insertion and maintenance is provided by a named person with professional experience of cannulation and phlebotomy (nurse or paramedic).

The intervention is delivered over 3 x 6 hour sessions, one of which includes a comparator drink, over a period of up to 4 weeks. The minimum washout period is 2 days between treatments.

The cannulation and urine collection take place either at the Massey Human Nutrition Unit (Massey University Turitea campus, Palmerston North) or at the Massey Sports and Exercise Science Laboratory (Massey University Wellington campus, Wellington).
Intervention code [1] 313381 0
Prevention
Comparator / control treatment
The comparator treatment drink is formulated with whey protein, at 11.2% protein content, 5% fat and 12% carbohydrate.
Control group
Active

Outcomes
Primary outcome [1] 318723 0
Primary outcome 1: Identification of the kinetics of amino acid release on digestion during the 5 hours post-ingestion, based on the concentration of plasma amino acids in peripheral blood as a comparison to the comparator whey protein drink. The kinetics of plasma amino acids are well-reported for whey protein.

Plasma amino acids to identified will be the 20 amino acids commonly found in food, apart from cysteine, (reported as cystine), and proline (reported as hydroxyproline). Additionally, taurine, citrulline, and ornithine, will be reported.
Timepoint [1] 318723 0
Timepoints: From fasting state to 5 hours after drink consumption, at 0, 30, 60, 90, 120, 180, 240 and 300 min.
Secondary outcome [1] 365821 0
Secondary outcome 1: Identification of differences in metabolite profile of urine metabolites between the three trial drinks. The whole metabolite profile is measured using NMR analysis, and statistical analysis applied to quantify the most significant differences, and individual metabolites contributing to these differences are then identified.
Timepoint [1] 365821 0
Timepoints: From fasting state to 5 hours after drink consumption (T0), at -60, 60, 180, and 300 min.
Secondary outcome [2] 371378 0
Secondary outcome 2: Determine and compare the satiating effect of the three drinks. Participants rate satiety (Hunger, Fullness, Prospective consumption, Desire to eat) on a Visual Analogue Scale of 0-10 cm. The questions are (Scale ends in brackets) ‘How hungry are you?’ (Not at all - Extemely), ‘How much food would you like to eat? (Nothing - A large amount)’, ‘How full are you?’ (Not at all full - Extremely full), and How strong is your desire to eat?’ (Very weak - Very strong).

Statistical analysis is applied to the time course data and to Area under the Curve determined by the trapezoid method.
Timepoint [2] 371378 0
Timepoints: From fasting state to 5 hours after drink consumption (T0), at -5, 60, 120, 150, 180, 240 and 300 min.
Secondary outcome [3] 371379 0
Secondary outcome 3: Determine and compare the effect on thirst rating of the three drinks. Participant thirst is assessed to evaluate differences between the three drinks. Thirst is rated assessed on a 10 cm Visual Analogue Score. The question (Scale ends in brackets) isasked 'How thirsty are you?' (Not at all thirsty-Extremely thirsty').

Statistical analysis is applied to the time course data and to Area under the Curve determined by the trapezoid method.
Timepoint [3] 371379 0
Timepoints: From fasting state to 5 hours after drink consumption (T0), at -5, 60, 120, 150, 180, 240 and 300 min.

Eligibility
Key inclusion criteria
BMI between 18-30
Healthy digestive system
Minimum age
50 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of chronic gastrointestinal, liver or kidney disorders
Ingesting high doses or multiple daily medication
Food allergies or intolerances
> 4 hours/week of high-intensity exercise
Personal or cultural objection to sampling of bodily fluids

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited into trial and randomly assigned a drink consumption order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence (drink order) x period (drink A B C) design is a Latin square
ABC
BCA
CAB
ACB
BAC
CBA
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)
Efficacy
Statistical methods / analysis
Data will be evaluated for normal distribution and the presence of outliers
A repeated-measures ANOVA will be used to evaluate the effect of time of rating and
drink sequence (drink × time) on plasma amino acid concentration and VAS-rated feelings ofhunger, desire to eat, prospective food consumption, fullness and thirst. In the case of a significant interaction between drink and time (P<0·05), Tukey's HSD test will be applied to to examine the drink and time combinations.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21211 0
New Zealand
State/province [1] 21211 0

Funding & Sponsors
Funding source category [1] 301679 0
Government body
Name [1] 301679 0
High Value Nutrition National Science Challenge
Address [1] 301679 0
Liggins Institute, University of Auckland, Private Bag 92019, Victoria St West, Auckland 1142 New Zealand
Country [1] 301679 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute, Massey University
Address
Riddet Institute, Massey University, Private Bag 11 222, Palmerston North 4442, New Zealand
Country
New Zealand
Secondary sponsor category [1] 301398 0
None
Name [1] 301398 0
Address [1] 301398 0
Country [1] 301398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302399 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 302399 0
Research Ethics, Research and Enterprise
Massey University, Private Bag 11 222, Palmerston North 4442, New Zealand
Ethics committee country [1] 302399 0
New Zealand
Date submitted for ethics approval [1] 302399 0
Approval date [1] 302399 0
31/10/2017
Ethics approval number [1] 302399 0
Southern A, Application 17/20

Summary
Brief summary
The MultiProMo trial is a nutritional study to evaluate the influence of food digestibility on amino acid metabolism in healthy men aged 50-70. On each trial day, fasted participants consume one of three high-protein drinks and provide blood and urine samples over 5 hours. This is a cross-over study, so each participant consumes all three drinks on separate days. Levels of amino acids and digestion-related metabolic compounds are measured in blood and urine, in order to understand the release and supply of nutrients for support skeletal muscle synthesis and maintenance. Participants rate satiety and thirst in the period after drink consumption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90102 0
Dr Teresa Francis Wegrzyn
Address 90102 0
Riddet Institute, Massey University, Private Bag 11 222, Palmerston North 4442,
Country 90102 0
New Zealand
Phone 90102 0
+64 6 951 9254
Fax 90102 0
Email 90102 0
T.F.Wegrzyn@massey.ac.nz
Contact person for public queries
Name 90103 0
Dr Teresa Francis Wegrzyn
Address 90103 0
Riddet Institute, Massey University, Private Bag 11 222, Palmerston North 4442,
Country 90103 0
New Zealand
Phone 90103 0
+64 6 951 9254
Fax 90103 0
Email 90103 0
T.F.Wegrzyn@massey.ac.nz
Contact person for scientific queries
Name 90104 0
Dr Teresa Francis Wegrzyn
Address 90104 0
Riddet Institute, Massey University, Private Bag 11 222, Palmerston North 4442,
Country 90104 0
New Zealand
Phone 90104 0
+64 6 951 9254
Fax 90104 0
Email 90104 0
T.F.Wegrzyn@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary