Protein, Blueberries + Exercise for Frailty

(STRONG Trial)

Not yet recruiting at 1 trial location

Overseen By Scott A Grandy, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Medical conditions, Cognitive conditions, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of protein supplements, blueberries, and exercise can reduce frailty and lower the risk of heart disease in older adults. Frailty accelerates aging and increases the likelihood of heart problems. The trial evaluates whether this lifestyle change can prevent heart issues and promote healthier aging. Participants will consume protein and blueberries daily and attend exercise sessions three times a week for a year. Ideal candidates are those aged 65 to 85 who have a heart disease risk factor and can engage in moderate exercise. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on lifestyle changes that may enhance heart health and reduce frailty.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention of protein, blueberries, and exercise is safe?

Research has shown that combining protein, blueberries, and exercise is generally safe for people. Studies on whey protein suggest it might boost brain health and reduce weakness without major side effects. Blueberries, rich in antioxidants, can enhance exercise performance and lower inflammation markers like IL-6 and CRP, which are linked to weakness. Exercise builds muscle and improves heart health, and it is usually safe when done in moderation. Overall, these elements are considered safe for most people, with any side effects typically being mild. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for frailty because it combines dietary supplements and exercise in a novel way to potentially improve physical health. Unlike standard frailty treatments that might focus solely on exercise or general nutrition advice, this approach delivers a specific combination of whey protein and blueberries, both known for their health benefits. Whey protein supports muscle growth and repair, while blueberries are rich in antioxidants that may reduce inflammation. Coupled with a structured exercise regimen, this treatment aims to enhance mobility and strength over a 12-month period, offering a comprehensive strategy to tackle frailty.

What evidence suggests that this trial's treatments could be effective for reducing frailty and cardiovascular disease risk?

This trial will evaluate the combination of protein, blueberries, and exercise as a treatment for frailty. Research has shown that this approach can reduce frailty by strengthening muscles, improving movement, and boosting heart health. Protein maintains muscle strength, while blueberries, rich in antioxidants, enhance blood flow and reduce inflammation. Exercise increases fitness and muscle strength, crucial for reducing frailty and improving heart health. Together, these elements support healthier aging and lower the risk of heart disease. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older Nova Scotians who may be at risk of cardiovascular disease and frailty. Participants should be interested in a year-long health strategy involving diet and physical activity to improve their heart health and reduce signs of aging.

Inclusion Criteria

I am between 65 and 85 years old.

Must be able to participate in a moderate intensity exercise program

Have at least one cardiovascular risk factor

Exclusion Criteria

Allergies and or dislike of blueberries and/or protein powder

I do not have any health or cognitive issues preventing me from joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STRONG intervention of protein, blueberries, and exercise for 12 months

12 months

First session in-person, subsequent sessions in-person or virtual

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Protein, Blueberries, and Exercise

Trial Overview The study tests if adding protein, blueberries, and exercise training to the daily routines of participants can lessen frailty and lower the risk of heart disease. It's a comprehensive approach that combines these three elements over a full year.

How Is the Trial Designed?

Group I: intervention of protein, blueberries, and exercise Active Control 2 Interventions

treatment groups will receive the STRONG intervention of 30g/day (1 scoop) of a colorless, tasteless whey protein isolate powder supplement and 1 cup (150 grams) of blueberries per day. They will also participate in three 60-minute multimodal exercise sessions per week. Each session will include a warm-up and cool-down (\~5 minutes each), 30 minutes of moderate intensity aerobic exercise and 20 minutes of moderate intensity resistance training. The intervention lasts for 12 months.

Group II: Control group Active Control 1 Intervention

Participants receive usual standard of care.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Dalhousie University, Canada

Collaborator

Trials

1

Recruited

240+

Published Research Related to This Trial

In a study of 200 community-dwelling older adults, frailty status was linked to protein intake, with frail individuals consuming less protein and branched-chain amino acids (BCAAs) compared to robust and pre-frail participants.

The relationship between frailty and protein consumption varied depending on the assessment tool used, indicating that the modified Fried's frailty phenotype (mFP) was particularly sensitive in identifying lower protein intake in frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein-Related Dietary Parameters and Frailty Status in Older Community-Dwellers across Different Frailty Instruments. Coelho-Júnior, HJ., Calvani, R., Picca, A., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06693271

Study Details | NCT06693271 | Investigating the Combined ... It is hypothesized that the addition of blueberries to a regimen of exercise plus protein will have synergistic beneficial effects on frailty and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12123748/

Berries and Steps: a protocol of a randomized, placebo ... We propose a study intervention protocol, which aims to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberries.

3. app.trialscreen.org app.trialscreen.org/trials/investigating-combined-effects-protein-blueberries-exercise-on-cardiovascular-trial-nct06693271

Investigating the Combined Effects of Protein, Blueberries ... Potential benefits of participating in this study include improved cardiovascular health, reduced frailty and risk of adverse health outcomes, increased muscle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6315527/

Effects of Protein Supplementation Combined with ... Our findings suggest that PS plus RET as well as MET is effective in improving frailty status, lean mass, muscle strength, and physical mobility in frail older ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051227624002838

Effects of Nutritional Supplementation Combined With ... This review evaluates the effectiveness of nutritional supplementation combined with exercise training on frailty characteristics, physical function, and ...

6. withpower.com withpower.com/trial/phase-cardiovascular-disease-cvd-2025-8e195

Protein, Blueberries + Exercise for Frailty (STRONG Trial) Trial Overview The study tests if adding protein, blueberries, and exercise training to the daily routines of participants can lessen frailty and lower the risk ...

7. trialx.com trialx.com/clinical-trials/listings/316611/the-impact-of-whey-protein-on-frailty-in-older-adults-classified-as-pre-frail/

The Impact of Whey Protein on Frailty in Older Adults ... This pilot study aims to determine the impact of whey protein supplementation on brain antioxidant levels and to assess the effects of whey ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6124147/

Assessing the Values of Blueberries Intake on Exercise ... Conclusion: The blueberry supplementation can potentially increase the exercise performance and decrease the IL-6 and CRP levels caused by an increased TAS ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07167277

The Impact of Whey Protein on Frailty in Older Adults ... Whey protein has the potential to increase brain antioxidant (GSH) levels by aiding in antioxidant synthesis. Frail older adults under-consume ...