Protein, Blueberries + Exercise for Frailty

(STRONG Trial)

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

240 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Protein, Blueberries, and Exercise for Frailty?

Research suggests that higher protein intake is linked to a lower risk of frailty in older adults, and combining dietary changes with exercise may be more effective in preventing and treating frailty. ^{1 2 3 4 5}

Is the combination of protein, blueberries, and exercise safe for humans?

Research suggests that good nutrition, including protein and fruit like blueberries, along with exercise, is generally safe and beneficial for older adults, especially in preventing frailty. ^{1 2 3 4 5}

How does the treatment of protein, blueberries, and exercise differ from other treatments for frailty?

This treatment is unique because it combines dietary changes with physical activity, focusing on increasing protein intake and adding blueberries, which are rich in antioxidants, along with exercise to address frailty. Unlike other treatments that may focus solely on medication or diet, this approach targets multiple aspects of health to improve overall resilience and reduce frailty. ^{3 6 7 8 9}

What is the purpose of this trial?

Cardiovascular diseases (CVD) are a leading cause of morbidity and mortality worldwide. While CVDs are predominantly diseases of aging, age itself does not predict CVD risk; people age at different rates. Frailty is a state of accelerated aging that increases the risk of adverse health outcomes. Frail people are at higher risk of developing CVDs, experiencing complications, and dying from these diseases than fit people of the same age. Indeed, frailty predicts the likelihood of developing CVD independently of traditional risk factors for CVD. It is known that older women are frailer than men and tend to express CVDs differently than men, but whether relationships between frailty and CVD are sex specific is unclear. It is possible that shared pathophysiological mechanisms such as chronic inflammation may help explain links between CVD and frailty. Importantly, the degree of frailty can be modified by lifestyle interventions. For example, sedentary lifestyles, food insecurity, and suboptimal dietary habits can exacerbate frailty whereas diet and exercise interventions can attenuate frailty. The investigators propose that a comprehensive health strategy targeting diet and physical activity to reduce frailty will reduce the risk of cardiovascular disease (CVD), thereby promoting healthy aging. Engaging in physical activity (e.g. exercise) helps improve aerobic fitness, increase muscle mass, promote cardiac regeneration, enhance metabolic function, regulate blood pressure, improve insulin sensitivity, reduce inflammation (a key frailty mechanism), and lessen frailty. High-quality dietary protein is essential to maintain muscle mass/function, preserve mobility, attenuate inflammation, and reduce frailty. Packed with antioxidants such as anthocyanins and flavonoids, with high levels of fiber, vitamins, and minerals, blueberries, a local Nova Scotian food, can help lower blood pressure, improve blood vessel function, reduce inflammation, and help the body utilize dietary protein. These are critical aspects of a strong heart and healthy aging. To date, many frailty intervention studies have been limited by small sample sizes, underrepresentation of women, and/or by testing individual lifestyle modifications rather than synergistic effects; additionally, none have investigated how reducing frailty impacts cardiovascular outcomes. Our goal is to determine if a year-long multidomain intervention of protein, blueberries, and exercise reduces frailty and cardiovascular disease risk in older at-risk Nova Scotians of both sexes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Protein intake and transitions between frailty states and to death in very old adults: the Newcastle 85+ study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Protein intake and incident frailty in the Women's Health Initiative observational study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition and Frailty: Opportunities for Prevention and Treatment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dairy Consumption and Risk of Frailty in Older Adults: A Prospective Cohort Study. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Association between Dietary Patterns and Frailty Prevalence in Shanghai Suburban Elders: A Cross-Sectional Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The association between dietary protein intake, energy intake and physical frailty: results from the Rotterdam Study. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Protein-Related Dietary Parameters and Frailty Status in Older Community-Dwellers across Different Frailty Instruments. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Protein Intake and Transition between Frailty States in Octogenarians Living in New Zealand. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Protocol for a randomised controlled trial of a primary care intervention to Reverse Frailty and Enhance Resilience through Exercise and dietary protein Education (REFEREE) in community-dwelling adults aged 65 and over. [2021]