Recruiting

CVD with Protein, Blueberries, Exercise

Sponsor:

Nova Scotia Health Authority

Code:

NCT06693271

Conditions

Cardiovascular Disease

Frailty

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

intervention of protein, blueberries

Exercise training

Study Details

Brief summary:

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.

Conditions

Cardiovascular Disease

Frailty

Study ID

NCT06693271

Start date

Dec 15, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be 65 years of age or above
  • Must be willing to participate in a low to moderate exercise program

Exclusion Criteria:

  • Medical and cognitive conditions that prevent participation in the intervention
  • Allergies and or dislike of blueberries and/or protein powder

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: intervention of protein, blueberries, and exercise

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. An alternate suitable protein powder such as pea protein isolate powder, pumpkin, casein, rice etc. is available for participants who do not eat milk products. 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.

no intervention: Control group

Participants receive usual standard of care.

Interventions

intervention of protein, blueberries

Intervention of 30g/day (1 scoop) of a colorless, tasteless whey protein isolate powder supplement and 1 cup (150 grams) of blueberries per day. An alternate suitable protein powder such as pea protein isolate powder, pumpkin, casein, rice etc. is available for participants who do not eat milk products.

Exercise training

Three 60-minute multimodal exercise sessions per week. Exercise interventions will be individualized to each participant based on their fitness level as per recommended guidelines for older adults. 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.

Primary outcome measure

  • Cardiovascular Risk - Echocardiography [ Time Frame: Baseline, 12 Months ]
  • Inflammatory Markers [ Time Frame: Baseline, 12 Months ]
  • Frailty [ Time Frame: Baseline, 3,6,9, and 12 months ]
  • Cardiovascualr Risk: Blood pressure [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  • Cardiovascualr Risk: Lipid Profile [ Time Frame: Baseline, 12 months ]
  • Frailty: Clinical Frailty Scale (CFS) [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  • Frailty: Pictorial Fit to frail Scale (PFFS) [ Time Frame: Baseline, 3, 6, 9, 12 months ]

Central Contacts and Locations

Central contacts

Locations

QEII Health Sciences Centre, Dickson Building

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Olivia Mercer

STRONG@nshealth.ca

Principal Investigator:

Scott A Grandy, PhD

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Cardiovascular Disease
  • Frailty
  • Blueberries
  • Exercise
  • Protein
  • Obesity
  • Hypertension
  • Hyperlipidemia
  • Sedentary Lifestyle
  • Older Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-08-28.