Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000650897
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
31/05/2021
Date last updated
9/05/2022
Date data sharing statement initially provided
31/05/2021
Date results information initially provided
9/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Deer Milk and nutrition in older adults.
Scientific title
The effect of deer milk on nutritional status and physical function in men and women over 65 years of age
Secondary ID [1] 304082 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Vitality
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 321338 0
Poor nutritional status 321339 0
Condition category
Condition code
Diet and Nutrition 319117 319117 0 0
Other diet and nutrition disorders
Musculoskeletal 319486 319486 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will recruit 120 seemingly healthy older adults between 65-80 years old. Two groups consuming either deer milk or the comparator drink. 200ml of each need to be consumed per day. The volunteers will also receive a physical activity questionnaire, a three-day dietary recall and complete the mini-nutritional assessment (MNA). The volunteers will consume the beverages for 10 weeks. Participants will receive a daily diary for recording consumption of the beverages as well as well as medications taken and any side effects due to consumption of the beverage.
Intervention code [1] 320413 0
Treatment: Other
Intervention code [2] 320414 0
Prevention
Comparator / control treatment
The comparator treatment, Fortisip, contains the following per 200ml: serve. 1250 kilojoules, 12 g protein, 11.6g fat, 10.4 g carbohydrate, 13.4g sugar, 180mg sodium, 182mg calcium.
The comparator beverage needs to be taken daily (200mL) for 10 weeks.
Participants will receive a daily diary in which they will record consumption, other medications and any side effects from consuming the beverage,
Control group
Active

Outcomes
Primary outcome [1] 327015 0
Grip strength will be measured using a HAND GRIP STRENGTH DYNAMOMETER
Timepoint [1] 327015 0
Week 0 and week 10 post-intervention.
Primary outcome [2] 327016 0
Nutritional status will be assessed using the Mini-Nutritional assessment form: MNA® is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition provided by Nestle Nutrition.
Timepoint [2] 327016 0
Week 0 and week 10 post-intervention.
Primary outcome [3] 327017 0
Body composition will be assessed using Tanita MC580 bio-impedance.
Timepoint [3] 327017 0
Week 0 and Week 10 postintervention.
Secondary outcome [1] 393472 0
Physical function assessment using the sit-to-stand test.
Timepoint [1] 393472 0
Week 0 and week 10 post intervention
Secondary outcome [2] 394747 0
Blood levels of 25(OH)D3 (vitamin D)
Timepoint [2] 394747 0
Week 0 and week 10 post intervention
Secondary outcome [3] 394748 0
Blood levels of iron
Timepoint [3] 394748 0
Week 0 and week 10 post intervention
Secondary outcome [4] 394749 0
Blood lipid profile
Timepoint [4] 394749 0
Week 0 and week 10 post intervention
Secondary outcome [5] 394750 0
Serum albumin
Timepoint [5] 394750 0
week 0 and week 10 post intervention
Secondary outcome [6] 394753 0
Serum High sensitivity C-reactive protein
Timepoint [6] 394753 0
week 0 and week 10 postintervention
Secondary outcome [7] 396209 0
Blood HBA1C
Timepoint [7] 396209 0
Week 0 and week 10 postintervention.

Eligibility
Key inclusion criteria
Willing to give consent and seemingly health and ambulant.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Milk allergy or lactose intolerant, regular use of protein supplements, severe malnutrition, diabetes or any endocrine disease.

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)
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
Efficacy
Statistical methods / analysis
The primary outcome measure for the power calculation is grip strength (GS) of the dominant hand measured at weeks 0 and week 10 post intervention. .
Previous studies investigating the effects of high protein nutritional supplementation in post-menopausal women and elderly men found differences of 10% in GS (2.5 in post-menopausal women and 4.1 in men). The residual standard deviation were 5 in post-menopausal women and 6.5 in men. This resulted in effect sizes of 0.5 and 0.6 standard deviations. The correlations between observations on the same subject were found to be around 0.5.
Sample size is calculated using the formula for normal data and a repeated measures design as described by Brown and Prescott (2006). Assuming a power of 80%, significance of 5%, two repeated measures per subject, and effect size of 0.5, and a within subject correlation of 0.5, n=48 subjects are required per group. To account for 20% attrition, n=120 subjects will be recruited (n=60 each for control and intervention groups). All outcomes will be presented using descriptive statistics; normally distributed data by the mean and standard deviation (SD) and skewed distributions by the median and interquartile range (IQR). Binary and categorical variables will be presented using counts and percentages. SAS 9.4 and SAS/STAT 15.1 will be used for all statistical analysis.
The subsections below will describe analyses in addition to the descriptive statistics.
Primary outcome
The primary analysis will compare the intervention with the control group using a linear mixed models approach to repeated measures analysis of variance (ANOVA). Grip strength (weeks 0 and 11) will be the dependent variable. Study subjects will be considered as random effects, treatment group and visit number as fixed effects. Adjusted mean grip strength for each time point and treatment group and the corresponding 95% confidence interval (CI) will be presented. A secondary analysis of the difference in grip strength between baseline and week 11 will be performed using analysis of covariance (ANCOVA). Treatment group will be included as a fixed effect and the baseline GS value will be included as a covariate. The estimated difference in mean change from baseline to week 11 and the corresponding 95 % (CI) will be presented.


Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Industry requirements and lack of further funding for employment.
Date of first participant enrolment
Anticipated
28/06/2021
Actual
6/08/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
31/03/2022
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
120
Accrual to date
Final
114
Recruitment outside Australia
Country [1] 23571 0
New Zealand
State/province [1] 23571 0
Albany, Auckland

Funding & Sponsors
Funding source category [1] 308218 0
Government body
Name [1] 308218 0
High Value Nutrition National Science Challenge
Country [1] 308218 0
New Zealand
Primary sponsor type
Government body
Name
High Value Nutrition
Address
The Liggins Institute, Building 505, 85 Park Road, Grafton, Auckland, New Zealand 1023
Country
New Zealand
Secondary sponsor category [1] 309003 0
Commercial sector/Industry
Name [1] 309003 0
Pamu
Address [1] 309003 0
Pamu Farms of New Zealand, 15 Allen Street, Te Aro, Wellington 6011
Country [1] 309003 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308199 0
Health and Disability Ethics Committee
Ethics committee address [1] 308199 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 308199 0
New Zealand
Date submitted for ethics approval [1] 308199 0
01/04/2021
Approval date [1] 308199 0
09/06/2021
Ethics approval number [1] 308199 0
21/CEN/107 Project Vitality

Summary
Brief summary
We hypothesise that deer milk will be an acceptable high protein beverage with natural high levels of vitamins and minerals and will therefore improve nutritional status.
The purpose of the proposed study is to assess if a natural milk with excellent nutritional properties is:
1) an acceptable oral supplement in older adults based on favourable sensory attributes
2) whether deer milk can improve nutritional status, body composition and physical performance as compared to a commercial over the counter nutritional supplement (ONS) .
Decline in nutritional status is a modifiable risk factor that directly impacts the development of malnutrition. The ability to influence disease progression through diet would be of significant benefit to ageing populations globally. Over the counter protein beverages are available to older adults, but poor compliance has been reported for many of these drinks which reduces the observed health benefits to the consumers. Deer milk is nutrient dense, has an improved taste and may affect mobility and general health of the participants – therefore compliance), body composition and biochemical assessments are included.
Purpose
The purpose of this study is to compare the effect of deer milk versus ONS on body composition, biochemical markers of nutrition, and low burden performance outcome measures.
Trial design
A randomised, double-blind, placebo-controlled, parallel group, longitudinal study. The trial will be completed by 120 (two groups of 60 each) women and men in the age range of 65-80 years dwelling in the community
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109902 0
Prof Marlena Kruger
Address 109902 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North Manawatu-Whanganui 4442
Country 109902 0
New Zealand
Phone 109902 0
+64 69517571
Fax 109902 0
Email 109902 0
[email protected]
Contact person for public queries
Name 109903 0
Prof Marlena Kruger
Address 109903 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North Manawatu-Whanganui 4442
Country 109903 0
New Zealand
Phone 109903 0
+64 69517571
Fax 109903 0
Email 109903 0
[email protected]
Contact person for scientific queries
Name 109904 0
Prof Marlena Kruger
Address 109904 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North Manawatu-Whanganui 4442
Country 109904 0
New Zealand
Phone 109904 0
+64 69517571
Fax 109904 0
Email 109904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential and not required to share


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
EmbaseA comparative intervention trial of deer milk and an oral nutritional supplement efficacy for improving older adults' nutritional status, muscle mass and physical performance.2023https://dx.doi.org/10.1016/j.clnesp.2023.07.018
N.B. These documents automatically identified may not have been verified by the study sponsor.