Investigating the Combined Effects of Protein, Blueberries, and Exercise on Cardiovascular Health and Frailty in Older Nova Scotians

NCT06693271 | Recruiting

• 1 other identifier: STRONG_2024-2027
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Functional Fitness

  Assessed using a 6-minute walk test (6MWT). Total distance in meters will be recorded.

  Baseline, 3,6,9, and 12 months

• Echocardiography

  Ejection fraction will be measured in M-mode and global longitudinal strain will be assessed.

  Baseline, 12 Months

• Inflammatory Markers

  Plasma will be obtained from blood samples collected at two time points, pre- and post-intervention. A multiplex assay will be used to quantify anti-inflammatory and inflammatory cytokines in the plasma sample. The following cytokines will be quantified (pg/ml): APRIL / TNFSF13, BAFF / TNFSF13B, sCD30 / TNFRSF8, sCD163, Chitinase-3-like, gp130 / sIL-6Rβ, IFN-α2, IFN-β, IFN-γ, IL-2, sIL-6Rα, IL-8, IL-10, IL-1, IL-12 (p40), IL-12 (p70), IL-19, IL-20, IL-22, IL-26, IL-27 (p28), IL-28A / IFN-λ2, IL-29/IFN-λ1, IL-32, IL-34, IL-35, LIGHT / TNFSF14, MMP-1, MMP-2, MMP-3, Osteocalcin, Osteopontin, Pentraxin-3, sTNF-R1, sTNF-R2, TSLP, TWEAK / TNFSF12.

  Baseline, 12 Months

• Frailty

  Frailty will be assessed using the Clinical Frailty Scale (CFS), Pictorial Fir-Frail Scale (PFFS), and Frailty Index

  Baseline, 3,6,9, and 12 months

• Cardiovascualr Risk: Blood pressure

  Resting blood pressure (systolic/diastolic) will be assessed using an automated blood pressure cuff. Blood pressure will be measure in mm of Hg.

  Baseline, 3, 6, 9, 12 months

• Cardiovascualr Risk: Lipid Profile

  Blood will be drawn by venipuncture and then sent to the hospital lab. There the lipid profile will be determined. Specifically, total cholesterol (mmol/L), triglycerides (mmol/L), low density lipoprotein (mmol/L) and high density lipoprotein (mmol/L) will be quantified.

  Baseline, 12 months

• Cardiovascualr Risk: Blood glucose

  After fasting for 12 hours the participants blood will be drawn by venipuncture. Blood samples will be sent to the hospital lab and fasting glucose (mmol/L) will be assessed.

  Baseline, 12 months

• Frailty: Clinical Frailty Scale (CFS)

  Frailty will be assessed using the CFS. The scale for the assessment ranges from 0 to 9, where 0 represents a robust individual and 9 represents terminally ill. A score of 4 or higher indicates frailty. This is a clinical judgement tool.

  Baseline, 3, 6, 9, 12 months

• Frailty: Pictorial Fit to frail Scale (PFFS)

  Frailty will be assessed with the PFFS. The PFFS is completed by the participant and uses visual images to assess their level of fitness/frailty. There are 14 sets of images on the PFFS. Each set contains 3-4 images and the participant is asked to pick the images that represents how they "usually" feel. The questionnaire is scored out of 43, with higher scores representing a higher degree of frailty.

  Baseline, 3, 6, 9, 12 months

• Household Foodwork Interactional Assessment 10 Questions (FIA-Q10)

  Household foodwork is "all the tasks a household does for eating". This includes the physical parts of foodwork (such as shopping, chopping, cooking, and cleaning) and the mental parts (such as budgeting, monitoring how much food is at home and what is needed, and remembering food allergies and special diets).

  Baseline, 6-month, 12-month, 1 year

• ASA24 Dietary Assessment Tool

  Baseline, 6-month, 12-month, 1-year.

Secondary Outcomes (6)

• Muscular Health: Lower Body Strength

  Baseline, 3,6,9, and 12 months

• Balance

  Baseline, 3,6,9, and 12 months

• Mobility: Lower Body

  Baseline, 3,6,9, and 12 months

• Overall Health

  Baseline, 3,6,9, and 12 months

• Muscular Health: Upper Body

  Baseline, 3, 6, 9, 12 months

Other Outcomes (2)

• Safety Outcomes

  Safety will be assessed at 1,3,6,9, and 12 months.

• Study Adherence

  On the last day of the month particpants will upload the months logbook. (e.g. On November 30th, participant would upload the November logbook). This will be done for every month the participant is in the study (i.e. 12 months).

Study Arms (2)

intervention of protein, blueberries, and exercise

ACTIVE COMPARATOR

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.

Dietary Supplement: intervention of protein, blueberries; Behavioral: Exercise training

Control group

NO INTERVENTION

Participants receive usual standard of care.

Interventions

intervention of protein, blueberries DIETARY_SUPPLEMENT

intervention of 30g/day (1 scoop) of a colorless, tasteless whey protein isolate powder supplement and 1 cup (150 grams) of blueberries per day.

intervention of protein, blueberries, and exercise

Exercise training BEHAVIORAL

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.

intervention of protein, blueberries, and exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (1)

QEII Health Sciences Centre, Dickson Building

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Frailty; Motor Activity; Obesity; Hypertension; Hyperlipidemias; Sedentary Behavior

Interventions

blueberry extract; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Scott A Grandy, PhD

CONTACT

902-494-4303; Scott.Grandy@Dal.Ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)