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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNova Scotia Health Authority

About 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 does not accept healthy volunteers

Qualifiers

Must be 65 years of age or above

Must be willing to participate in a low to moderate exercise program

Disqualifiers

Medical and cognitive conditions that prevent participation in the intervention

Allergies and or dislike of blueberries and/or protein powder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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. 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

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: intervention of protein, blueberries, and exerciseActive comparator 2 interventions
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Cardiovascular Risk - Echocardiography

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

Time frame
Baseline, 12 Months
2

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.

Time frame
Baseline, 12 Months
3

Frailty

Frailty will be assessed using a Frailty Index. The frailty index will be constructed based on deficit accumulation using established techniques

Time frame
Baseline, 3,6,9, and 12 months
4

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.

Time frame
Baseline, 3, 6, 9, 12 months

Secondary outcomes

1

Muscular Health: Lower Body Strength

Lower body strength will be assessed using the 30 second sit to stand task. The number of times an individual can stand from a seated position will be recorded.

Time frame
Baseline, 3,6,9, and 12 months
2

Functional Fitness

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

Time frame
Baseline, 3,6,9, and 12 months
3

Balance

Single leg balance test. Total time in seconds will be recorded.

Time frame
Baseline, 3,6,9, and 12 months
4

Mobility: Lower Body

Lower body mobility will be assessed using the sit \& reach test. Reach distance will be measured in centimeters.

Time frame
Baseline, 3,6,9, and 12 months

Other outcomes

1

Safety Outcomes

Safety outcomes will be determined by recording the total number of adverse events that occur over the duration of the exercise program. This will be divided by the number of participant hours to determine the number of adverse events/participant hours.

Time frame
Safety will be assessed at 1,3,6,9, and 12 months.
2

Study Adherence

Exercise attendance and blueberry/protein consumption will be monitored using an electronic participant logbook.

Time frame
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).
3

Incident Outcomes Related to Frailty

Impaired balance, falls, hip fractures, changes in like-space, social engagement.

Time frame
Baseline, 3, 6, 9, 12 months
4

CVD

Angina, heart attack, stroke.

Time frame
12 months

Sponsors and contacts

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Nova Scotia Health Authority

Lead sponsor

Dalhousie University

Collaborator