Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001181796
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
2/09/2022
Date last updated
2/09/2022
Date data sharing statement initially provided
2/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Curcumin-Fortified Whey Protein Beverage on Exercise-Induced Muscle Damage in Older Adults
Scientific title
Effect of Curcumin-Fortified Whey Protein Beverage on Exercise-Induced Muscle Damage in Older Adults
Secondary ID [1] 307820 0
None
Universal Trial Number (UTN)
Trial acronym
Turmeric Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-Induced Muscle Damage 327417 0
Condition category
Condition code
Musculoskeletal 324546 324546 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Turmeric Study is a randomised, controlled 4-day intervention trial designed to examine the effect of curcumin-fortified whey protein beverage supplementation on exercise-induced muscle damage in healthy older adults aged 65-80 years living in Auckland, New Zealand.

This study will take place at the Sports and Exercise Lab, Massey University, Albany Campus.

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.

At the lab, participants will undergo familiarization with the strain gauge machine and assessment of 1-Repetition Max (1-RM) on the leg-press machine on two occasions. The familiarization sessions will take an hour and will be separated by two days. Two days after the second familiarization visit, they will come to the lab for the main trial spread across a four-day period.

On day 1 of the main trial, participants will report their baseline measures for sleep, muscle soreness, how they feel, force measures on the strain gauge, and blood samples for inflammatory markers. This will be followed by the muscle-damaging exercise protocol. The exercise consists of 5 minutes of warming-up on a cycle ergometer, followed by 6 sets of 6 repetitions in each set on leg press machine, and a 5-minute cooling-down period on the cycle ergometer. Two minutes of rest will be given between sets and 5 min between each leg. The workload for each exercise will be 80% of 1-repetition maximum previously assessed at the familiarization visit. The participants will consume the allocated beverage immediately after the completion of the exercise intervention along with a standardized breakfast (2 slices of white toast with peanut butter). They will then remain in the lab for the next 2 hours to provide blood samples, force measures, and rate the feeling scale and scale for muscle soreness.

Participants will come to the lab 24 h (day 2), 48 h (day 3), and 72 h (day 4) after the completion of the exercise intervention to provide blood samples and force measures and provide ratings from the sleep questionnaire, feeling scale and muscle soreness.

On day 2 of the main trial (first follow-up visit), participant will consume the assigned beverage (second supplement) along with breakfast after completing the reassessment of baseline measures. There will be no supplementation for days 3 and 4 of the main trial.

All activities will be conducted under clinical monitoring at the sports lab.

Fortified whey protein beverage will contain 15 g of protein and 500 mg of curcumin, whey protein beverage will contain 15 g of protein and yellow food colour, and placebo beverage will contain 15 g of maltodextrin and yellow food colour. All beverages will be isocaloric.

Intervention code [1] 324287 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 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] 332368 0
Force measures for knee extensors assessed on strain gauge machine
Timepoint [1] 332368 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Primary outcome [2] 332369 0
Visual Analogue Scale for assessment of Muscle Soreness
Timepoint [2] 332369 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Primary outcome [3] 332370 0
Creatine Kinase from the blood plasma as a marker of inflammation for exercise-induced muscle damage
Timepoint [3] 332370 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [1] 413217 0
C-Reactive Protein the blood plasma as a marker of inflammation for exercise-induced muscle damage
Timepoint [1] 413217 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [2] 413218 0
Interleukin-6 from the blood plasma as a marker of inflammation for exercise-induced muscle damage
Timepoint [2] 413218 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [3] 413219 0
Interleukin-10 from the blood plasma as a marker of inflammation for exercise-induced muscle damage
Timepoint [3] 413219 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [4] 413220 0
Tumour-Necrosis Factor from the blood plasma as a marker of inflammation
Timepoint [4] 413220 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [5] 413221 0
Glutathione Peroxidase from the blood plasma as a marker of oxidative damage after exercise
Timepoint [5] 413221 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [6] 413222 0
Superoxide Dismutase from the blood plasma as a marker of oxidative damage after exercise
Timepoint [6] 413222 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [7] 413223 0
Feeling Scale to understand how participants feel throughout the trial after a muscle-damaging exercise
Timepoint [7] 413223 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.
Secondary outcome [8] 413224 0
Leeds Sleep questionnaire to understand how participants slept throughout the trial after a muscle-damaging exercise
Timepoint [8] 413224 0
Before (at baseline) and at 1 h, 2h, 24 h, 48 h, and 72 h after the completion of the exercise protocol.

Eligibility
Key inclusion criteria
Participants must be proficient in English and must be between the ages of 65-85 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
85 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 and if they have had knee/joint injuries in the past 6 months and 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 participant 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
5/09/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
12/08/2023
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 24971 0
New Zealand
State/province [1] 24971 0
Auckland

Funding & Sponsors
Funding source category [1] 312091 0
University
Name [1] 312091 0
Massey University
Country [1] 312091 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] 313614 0
None
Name [1] 313614 0
None
Address [1] 313614 0
None
Country [1] 313614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311497 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 311497 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311497 0
New Zealand
Date submitted for ethics approval [1] 311497 0
17/06/2022
Approval date [1] 311497 0
13/07/2022
Ethics approval number [1] 311497 0
2022 EXP 11720

Summary
Brief summary
As we age, there is an increase in body fat that causes low-grade inflammation. Additionally, a subsequent decrease in muscle mass and strength leads to a functional decline, hindering daily activities over time. This decline in muscle function is called sarcopenia. We can slow down its progression and improve the quality of life with two simple measures – improve our protein intake and engage in strength training. However, strength training causes exercise-induced muscle damage that triggers a release of inflammatory markers and can increase the pre-existing inflammation.

Curcumin – the active compound in turmeric – is a natural antioxidant and anti-inflammatory agent. It has the potential to decrease low-grade inflammation and improve exercise-induced muscle damage. On the other hand, whey protein has been shown to increase muscle mass and strength when consumed within 30 min post-workout. Thus, this project aims to combine whey protein isolate and curcumin, an anti-inflammatory agent, to obtain a combined effect that decreases the exercise-induced inflammation post workout and helps in faster recovery.

Participants will be recruited through flyers and advertisements and will be divided into three treatment groups - (a) curcumin-fortified whey protein beverage group, (b) whey protein group, or (c) placebo group. Two familiarizations will be conducted to master the movements on the stain gauge and leg-press machine. This will be followed by a four-day main trial at the lab. Participants will provide baseline measures and then engage in 6 sets of 6 repetitions in each set on the leg press machine at their 80% 1-repetition maximum. Participants will consume the assigned beverage immediately after completion of exercise and then provide follow-up measures at 1, 2, 24, 48, and 72 hour post-exercise. The assigned beverage will also be consumed at the 24-hour visit after completing the follow-up measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121306 0
Miss Krutika Nanavati
Address 121306 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 121306 0
New Zealand
Phone 121306 0
+64 21 145 1392
Fax 121306 0
Email 121306 0
k.nanavati@massey.ac.nz
Contact person for public queries
Name 121307 0
Miss Krutika Nanavati
Address 121307 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 121307 0
New Zealand
Phone 121307 0
+64 21 145 1392
Fax 121307 0
Email 121307 0
k.nanavati@massey.ac.nz
Contact person for scientific queries
Name 121308 0
Miss Krutika Nanavati
Address 121308 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 121308 0
New Zealand
Phone 121308 0
+64 21 145 1392
Fax 121308 0
Email 121308 0
k.nanavati@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
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.