Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001065280
Ethics application status
Approved
Date submitted
13/06/2018
Date registered
26/06/2018
Date last updated
26/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the nutritional quality of meat protein powder in older adults.
Scientific title
Postprandial metabolic utilization of a 15N labelled lamb meat protein hydrolysate in older adult humans.
Secondary ID [1] 295185 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related muscle loss 308320 0
Condition category
Condition code
Diet and Nutrition 307319 307319 0 0
Other diet and nutrition disorders
Musculoskeletal 307350 307350 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomized parallel design metabolic study. The aim is to determine the net postprandial protein utilisation (NPPU) and postprandial biological value (PBV) of a lamb meat protein hydrolysate in older adults and to compare this with the NPPU and PBV of a dairy protein, casein. Dairy proteins are considered the gold standard for protein digestibility and utilisation in the body. The study will be conducted at Massey University in the Human Nutrition Research Unit by Dr Sharon Henare, physiologist, who has 13 years experience conducting nutrient digestibility and utilisation studies and two registered nurses. The intervention will be one 9-h session following an overnight fast from 10pm to when the participant arrives at the research unit the next morning. Fasting will involve not eating any foods or drinking any liquids. To ensure participants remember to fast a text message reminder will be sent at 9pm. On arrival to the research unit the next morning and before the intervention, participants will be asked whether they ate or drank during the fasting period. Individual participants will be required to consume a single mixed meal that contains 30 g of protein from either 15N-labelled lamb hydrolysate or 15N-labelled casein as the sole source of protein, 15 g of fat from canola oil and 55 g of carbohydrate from maltodextrin mixed in to 400 ml of water. The lamb hydrolysate mixture will be blended with a whisk over heat and served at 60°C. The casein mixture will be blended and served at room temperature. Blood and urine samples will be collected from participants before consuming the meal and then 30, 60, 90, 120,150, 180, 240, 300, 360, 420 and 480 min after the meal for blood and 2, 4, 6 and 8 h after the meal for urine. Analyses will determine where in the body the nitrogen from each protein source is utilised and the data used to calculate NPPU and PBV.
Intervention code [1] 301524 0
Treatment: Other
Comparator / control treatment
The treatment meal is consumption of a mixed meal containing 30 g of protein from lamb meat hydrolysate protein. The comparator is the same mixed meal containing 30 g of protein from casein.
Control group
Active

Outcomes
Primary outcome [1] 306279 0
Net postprandial protein utilisation (NPPU) determined from nitrogen concentrations in blood and urine samples.
Timepoint [1] 306279 0
Nitrogen concentrations determined in blood samples collected at time 0 (pre-meal), 60, 120, 180, 240, 300, 360, 420 and 480 minutes and in urine samples collected at time 0 (pre-meal), 2, 4, 6 and 8 hours after consumption of the meal.
Primary outcome [2] 306280 0
Postprandial biological value determined from nitrogen concentrations in blood and urine samples and digestibility values determined in a previous study (Awati et al., 2008).

Awati A., Rutherfurd S., Qui J., Veyry A., Henare S., Singh H. & Moughan PJ (2008). Determination of true ileal digestibility and digestible amino acid contents of the lamb meat hydrolysate. Research report prepared for Meat Biologics Research Ltd.
Timepoint [2] 306280 0
Nitrogen concentrations determined in blood samples collected at time 0 (pre-meal), 60, 120, 180, 240, 300, 360, 420 and 480 minutes and in urine samples collected at time 0 (pre-meal), 2, 4, 6 and 8 hours after consumption of the meal.
Secondary outcome [1] 348061 0
Dietary nitrogen that enters the body urea pool.
Timepoint [1] 348061 0
Nitrogen concentrations determined in blood samples collected at time 0 (pre-meal), 60, 120, 180, 240, 300, 360, 420 and 480 minutes after the consumption of the meal.
Secondary outcome [2] 348329 0
Dietary nitrogen that enters the urinary urea pool.
Timepoint [2] 348329 0
Nitrogen concentrations determined in urine samples collected at time 0 (pre-meal), 2, 4, 6 and 8 hours after the consumption of the meal.
Secondary outcome [3] 348330 0
Dietary nitrogen that enters the urinary ammonia pool.
Timepoint [3] 348330 0
Nitrogen concentrations determined in urine samples collected at time 0 (pre-meal), 2, 4, 6 and 8 hours after the consumption of the meal.
Secondary outcome [4] 348331 0
Change in plasma glucose concentrations.
Timepoint [4] 348331 0
Glucose concentrations determined in blood samples collected at time 0 (pre-meal), 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes after the consumption of the meal.
Secondary outcome [5] 348332 0
Change in serum insulin concentrations.
Timepoint [5] 348332 0
Insulin concentrations determined in blood samples collected at time 0 (pre-meal), 30, 60, 90, 120, 150, 180, 240, 300, 360, 420 and 480 minutes after the consumption of the meal.

Eligibility
Key inclusion criteria
60 years of age or older
Be in good general health
Not vegetarian or vegan
Not suffering from any disorders of digestion or taking medication that affects the gut
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have had gastrointestinal surgery or a gastrointestinal disorder
Have had or have hepatic or liver disorder
Have a urinary tract disorder
Have had or have a blood borne disease (example: hepatitis B or C)
Have a bleeding or clotting disorder
Have had gall bladder surgery
Have a bowel disorder
Have a cardiac disease (heart disease)
Are diabetic
Smoke cigarettes
Consume more than 2 glasses of wine or 1 pint of beer a day
Have allergies to dairy products or eggs
Have experienced significant weight loss during the past six months
Are taking medications that affect digestion

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
The number of participants was calculated using a standard calculation of sample size (2 tailed test according to Fitzmaurice (2002) using the following equation:

n = 2 s2 (Z1 – a/2 + Z1 - ß) 2
d2
where
• s is the standard deviation of the measurements
• Z1 – a/2 and Z1 – ß denote the (1 – a/2) x 100 % and (1 – ß) x 100 % percentiles respectively of a standard normal distribution (eg: the 97.5th percentile of a standard normal distribution is 1.96 or 97.5 % of the area under the bell-shaped standard normal curve lies to the left of 1.96)
• a is the type 1 error (significance level) and = 0.05
• ß is the type 2 error (power) and = 0.1 (power of 90%)
• d is the effect size (minimum difference to be detected)

Two separate analyses were conducted using values from the literature. The values used were obtained from experiments conducted in humans using a similar methodology as in the present experiment and were based on 1) dietary nitrogen concentrations in the body urea pool and 2) dietary nitrogen concentrations in the serum nitrogen pool.
Fitzmaurice G 2002 Sample size and power: How big is big enough? Nutrition 18 289-290

Data will be evaluated following normal distribution and homogeneity of variances tests with general linear model repeated measures analyses of variance to compare differences between meals over time for hormones and dietary nitrogen kinetics with posthoc comparisons. Area under the curve will be determined using the trapezoid rule.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/02/2008
Date of last participant enrolment
Anticipated
Actual
11/08/2008
Date of last data collection
Anticipated
Actual
29/08/2008
Sample size
Target
31
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 10555 0
New Zealand
State/province [1] 10555 0
Manawatu

Funding & Sponsors
Funding source category [1] 299771 0
Commercial sector/Industry
Name [1] 299771 0
Meat Biologics Research Limited
Country [1] 299771 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Tennent Drive
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 299115 0
None
Name [1] 299115 0
Address [1] 299115 0
Country [1] 299115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300661 0
Massey University Ethics Committee Southern A
Ethics committee address [1] 300661 0
Ethics committee country [1] 300661 0
New Zealand
Date submitted for ethics approval [1] 300661 0
06/08/2007
Approval date [1] 300661 0
05/10/2007
Ethics approval number [1] 300661 0
07/53

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

Contacts
Principal investigator
Name 84382 0
Dr Sharon Henare
Address 84382 0
School of Health Sciences
College of Health
Massey University
Private Bag 11222
Palmerston North 4442
Country 84382 0
New Zealand
Phone 84382 0
+64 6 3569099 x84289
Fax 84382 0
Email 84382 0
[email protected]
Contact person for public queries
Name 84383 0
Sharon Henare
Address 84383 0
School of Health Sciences
College of Health
Massey University
Private Bag 11222
Palmerston North 4442
Country 84383 0
New Zealand
Phone 84383 0
+64 6 3569099 x84289
Fax 84383 0
Email 84383 0
[email protected]
Contact person for scientific queries
Name 84384 0
Sharon Henare
Address 84384 0
School of Health Sciences
College of Health
Massey University
Private Bag 11222
Palmerston North 4442
Country 84384 0
New Zealand
Phone 84384 0
+64 6 3569099 x84289
Fax 84384 0
Email 84384 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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