Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001058763
Ethics application status
Approved
Date submitted
25/07/2022
Date registered
29/07/2022
Date last updated
29/07/2022
Date data sharing statement initially provided
29/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Curcumin-Fortified Whey Protein Beverage and Strength Training
on Physical Performance in Older Adults
Scientific title
Effect of Curcumin-Fortified Whey Protein Beverage and Strength Training
on Physical Performance in Older Adults
Secondary ID [1] 307643 0
None
Universal Trial Number (UTN)
Trial acronym
Building Muscle Mass Study (BMM Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 327164 0
Condition category
Condition code
Musculoskeletal 324280 324280 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BMM Study is a randomised, controlled 8-week intervention trial designed to examine the effect of curcumin-fortified whey protein beverage supplementation and strength training sessions on physical performance in healthy older adults aged 65-80 years living independently at retirement villages across Auckland, New Zealand.

This study will take place in retirement villages, and participants will engage in the intervention from their respective villages. Thus, there are no visits to the lab.

Enrolled participants will be assigned to any one of the three beverage groups: (a) curcumin-fortified whey protein beverage group, (b) whey protein group, or (c) placebo group.

A research team consisting of coordinating investigator and research assistants will come to the retirement village to conduct a baseline assessment of anthropometry measures and physical performance. After completing the baseline assessment, a certified personal trainer will come to the retirement village three times a week for eight weeks to conduct strength training sessions.

Strength training sessions will be about 45 mins to 1 hour long, and use medium and heavy strength resistance bands for the exercises. Exercises will include resistance band seated row, banded squats, resistance band lateral raise (to name a few) - 4 sets of 15-20 reps with medium resistance bands for weeks 1-4. The exercises will progress to resistance band bicep curl, banded front & side lateral raises, resistance band push-ups with taps, step-ups, and more – 3 sets of 10-20 reps with the heavy resistance band. Exercises will vary from week to week to add variety to the sessions. Strength training sessions will take place in groups of no more than 10 participants at the retirement village.

Participants will consume the assigned supplement under the personal trainer’s supervision and fill out a training log within 30 mins of completing every strength training session i.e., three sessions per week: a total of 24 sessions across eight weeks. Participants will receive the powdered supplement in the form of sachets that will be mixed with 250-300 ml of water.

At the end of 8 weeks, our research team will again come to the retirement village to conduct a reassessment of all baseline measures, and that would be marked as the completion of the trial.

Fortified whey protein beverage will contain 15 g of protein and 150 mg of curcumin, whey protein beverage will contain 15 g of protein and yellow food colour, and placebo beverage will contain maltodextrin and yellow food colour. All beverages will be isocaloric.
Intervention code [1] 324097 0
Lifestyle
Intervention code [2] 324110 0
Prevention
Intervention code [3] 324111 0
Treatment: Other
Comparator / control treatment
Control treatment for curcumin-fortified whey protein will be maltodextrin powder mixed with powdered yellow food colour. 15 g of the yellow maltodextrin supplement will be mixed with 250 ml of water and consumed immediately after the strength training session.
Control group
Placebo

Outcomes
Primary outcome [1] 332089 0
Number of steps in the 2-minute step test
Timepoint [1] 332089 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Primary outcome [2] 332090 0
Grip strength test assessed using a hand dynamometer
Timepoint [2] 332090 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Primary outcome [3] 332091 0
Assessment of agility and dynamic balance using 2.45-m up-and-go test
Timepoint [3] 332091 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [1] 412176 0
Chair stand test to assess lower-body strength
Timepoint [1] 412176 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [2] 412177 0
To assess upper-body strength using bicep curl test
Timepoint [2] 412177 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [3] 412178 0
To assess lower-body (primarily hamstring) flexibility using chair sit and reach test
Timepoint [3] 412178 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [4] 412179 0
To assess upper-body (shoulder) flexibility with back scratch test
Timepoint [4] 412179 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [5] 412268 0
Focus Groups for assessment of qualitative measures.

Participating in focus groups is optional. Focus groups will take place at the retirement villages where the participants reside, and 5-6 individuals per beverage group would participate.

For the focus group session before the trial, the questions would be about what you think about the study, how you feel about participating in the study, what could be barriers to commitment to the study and more. For the session after the trial, the questions would be about how you found the strength training program, what you enjoyed the most, what could be done better, and more.

The session will be audio-recorded on a mobile phone and through notes on paper. The identities of the participants will be confidential.
Timepoint [5] 412268 0
Prior to the beginning of strength training session 1 at week 1, and post reassessment of baseline measures i.e., after 9 weeks of intervention commencement.
Secondary outcome [6] 412269 0
Weight assessed using electronic standing scales
Timepoint [6] 412269 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [7] 412270 0
Questionnaire: 36-Item Short Form Survey (SF-36) as a measure of health
Timepoint [7] 412270 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [8] 412271 0
Anthropometry measure in the form of waist circumference using a measuring tape
Timepoint [8] 412271 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [9] 412272 0
Anthropometry measure in the form of hip circumference using a measuring tape
Timepoint [9] 412272 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [10] 412273 0
Anthropometry measure in the form of calf circumference using a measuring tape
Timepoint [10] 412273 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [11] 412274 0
Anthropometry measure in the form of thigh circumference using a measuring tape
Timepoint [11] 412274 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).
Secondary outcome [12] 412275 0
Anthropometry measure in the form of mid-upper arm circumference using a measuring tape
Timepoint [12] 412275 0
Baseline, 9 weeks post-intervention commencement (i.e., 3 days after completion of 24th strength training session at week-8 of the intervention period).

Eligibility
Key inclusion criteria
Participants must be proficient in English and must be between the ages of 65-80 years old. They should have not engaged in strength training or consumed protein and curcumin supplements in the last 6 months. They must be able to provide a medical clearance from GP to be eligible to take part in this trial.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential healthy participants will be excluded if they are smokers. Further, participants will be excluded if they are on any prescribed medication for diseases related to kidneys, pancreas, liver, etc. and other chronic diseases. They will also be excluded if they have had knee/joint injuries in the past six months and are on the management of osteoarthritis through medication.

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 of the participants will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be established using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to G*Power analysis (F tests - ANOVA: Repeated measures, within factors), for an effect of 0.5 with a power of 0.8 at an alpha level of p < 0.05 for three groups with two-time points, the estimated sample size is 12. However, due to the potential for participants drop out, we aim to recruit 20 participants per group.

SPSS will be used for statistical analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24915 0
New Zealand
State/province [1] 24915 0
Auckland

Funding & Sponsors
Funding source category [1] 311905 0
University
Name [1] 311905 0
Massey University
Country [1] 311905 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 313389 0
None
Name [1] 313389 0
Address [1] 313389 0
Country [1] 313389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311341 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 311341 0
Ethics committee country [1] 311341 0
New Zealand
Date submitted for ethics approval [1] 311341 0
17/06/2022
Approval date [1] 311341 0
26/07/2022
Ethics approval number [1] 311341 0
2022 EXP 12905

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

Contacts
Principal investigator
Name 120774 0
Miss Krutika Nanavati
Address 120774 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 120774 0
New Zealand
Phone 120774 0
+64 211451392
Fax 120774 0
Email 120774 0
[email protected]
Contact person for public queries
Name 120775 0
Krutika Nanavati
Address 120775 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 120775 0
New Zealand
Phone 120775 0
+64 211451392
Fax 120775 0
Email 120775 0
[email protected]
Contact person for scientific queries
Name 120776 0
Krutika Nanavati
Address 120776 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 120776 0
New Zealand
Phone 120776 0
+64 211451392
Fax 120776 0
Email 120776 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
Trial data will remain anonymised throughout the trial. No external researchers or databases will have access to individual data.


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
No additional documents have been identified.