- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441343
Effects of Polyphenol Supplementation and Exercise on Physical Performance in Older Adults
Effects of Polyphenol Supplementation and Exercise on Physical Performance in Older Adults: A Randomized Controlled Pilot Feasibility Trial
After approximately age 40 years, individuals experience a natural loss of muscle mass, strength, and physical function that is linked to higher risks of falls, disability, loss of independence, and mortality. These losses can also be a precursor to the development of frailty, which includes factors beyond impaired physical function such as cognitive impairment, psychological disorder, increased likelihood of hospitalization, need of long term-care, and mortality. Structured exercise-encompassing both resistance and aerobic training-is widely recognized as an effective lifestyle intervention for improving muscle health, cardiovascular capacity, and overall physical function in older adults. However, aging is accompanied by chronically elevated systemic inflammation, and although exercise remains highly beneficial, older adults exhibit a heightened inflammatory response to training and a diminished capacity for post-exercise recovery.
Polyphenols, a group of naturally occurring bioactive compounds, have been shown to possess both anti-inflammatory and antioxidant benefits, positively impacting recovery and health. Polyphenol supplementation, particularly when paired with structured exercise, may elicit synergistic improvements in physical performance through combined effects on oxidative stress, inflammation, and muscle recovery, making polyphenols a compelling adjunct strategy for mitigating sarcopenia. In pursuit of refining strategies that support healthy aging and preserve functional capacity in older adults, this study aimed to determine the feasibility of implementing a 12-week resistance and aerobic exercise program combined with dietary supplementation in older adults.
Participants will either consume a polyphenol blend or a placebo control of maltodextrin daily whilst undergoing 12 weeks of supervised resistance and aerobic exercise. Additionally, this study will test the hypothesis that polyphenol supplementation will augment the exercise-induced improvements in physical function and muscle health. Further, exploratory analyses of skeletal muscle biopsy and venous plasma samples will aid in elucidating the potential geroprotective effects of polyphenols at both cellular and molecular levels.
Study Overview
Status
Conditions
Detailed Description
Life expectancy in Canada continues to rise, and by 2068 more than one-quarter of the population will be over the age of 65 years. Although Canadians are living longer, added years are not necessarily lived in good health. Aging is associated with increased sedentary behaviour, reduced physical performance, higher prevalence of chronic disease, and greater healthcare use. Sedentary behaviour, physical inactivity, and poor dietary habits accelerate age-related functional decline and contribute to chronic low-grade inflammation, a key driver of frailty, disability, and loss of independence in older adults. Exercise is strongly recommended to mitigate these risks, with clear dose-response benefits for all-cause and cardiovascular mortality; however, adherence can be limited, and age-related inflammation may blunt beneficial exercise adaptations. This underscores the need for accessible lifestyle strategies that support muscle function, physical performance, and healthy aging.
Polyphenols-naturally occurring bioactive compounds found in fruits and vegetables-have demonstrated anti-inflammatory and antioxidant effects relevant to exercise recovery and muscle adaptation. The investigational supplement used in this study (Phyto-P) contains a six-polyphenol blend including chlorogenic acid, chicoric acid, anthocyanins, and quercetin derivatives. Preclinical and human trials of individual polyphenols show reductions in inflammatory cytokines, improvements in antioxidant capacity, and attenuation of exercise-induced muscle damage. Despite these promising findings, it remains unknown whether a multi-polyphenol blend such as Phyto-P can enhance exercise-induced improvements in muscle strength, functional capacity, or molecular markers of skeletal muscle adaptation in older adults.
The purpose of this randomized, double-blind, placebo-controlled pilot feasibility trial is to determine whether it is practical to deliver a 12-week combined resistance band and aerobic exercise intervention with daily polyphenol supplementation in older adults. Feasibility outcomes-including recruitment, retention, exercise adherence, and supplement adherence-will determine whether a larger, fully powered efficacy trial is achievable. Secondary, exploratory outcomes will assess changes in physical function, muscular strength and power, skeletal muscle health and fiber-type distribution, cardiorespiratory fitness, self-reported well-being, and blood biomarkers, offering preliminary mechanistic insight to guide hypothesis generation for future studies.
Participants aged ≥60 years will be recruited from the Kingston community and complete screening, baseline assessments, a 12-week supervised exercise program paired with polyphenol or placebo supplementation, a midpoint assessment at week 6, and post-intervention testing that mirrors baseline procedures. The data generated from this pilot study will inform the design, methodology, and sample size requirements of future large-scale randomized controlled trials aimed at improving skeletal muscle health, physical function, and healthy aging through combined nutritional and exercise-based strategies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chris McGlory, PhD
- Phone Number: 75410 613-533-6000
- Email: chris.mcglory@queensu.ca
Study Locations
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-
Ontario
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Kingston, Ontario, Canada, K7L 3N6
- Recruiting
- Queen's University School of Kinesiology & Health Studies
-
Contact:
- Chris McGlory, PhD
- Phone Number: 75410 613-533-6000
- Email: chris.mcglory@queensu.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female or Male
- Age > 60y
- Non-Smoking
- English Speaking
Exclusion Criteria:
- Self-reported highly trained individual (training >3x/week for a specific sport with the goal to compete at a high level)
- BMI < 18.5
- Uses insulin to control blood glucose levels
- Any medical, orthopaedic, or psychiatric condition that would be comprise ability to comply with study requirements
- Regular user of anti-inflammatory and/or analgesic medication
- History of neuromuscular disorder or muscle/bone wasting disease
- Determined not ready for exercise by the CSEP GAQ
- Use of medication known to affect protein metabolism
- Family history of thrombosis, platelet or coagulation disorders, or antiplatelet therapy
- Use of anticoagulant medication
- Personal or family history of clotting disorder or deep vein thrombosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Polyphenol Supplement + Exercise
12-Week Daily consumption of 3g of Phyto-P (polyphenol-rich extract: chlorogenic acid (30.15 mg), chicoric acid (13.44 mg), 3,4-dicaffeoylquinic acid (8.43 mg), quercetin-3-O-glucoside (15.81 mg), quercetin-3-O-malonyl glucoside (33.00 mg), and anthocyanins (30.57
mg)) taken as capsules starting the first day of 12 weeks of exercise.
Supervised group resistance and aerobic exercise performed 4x/week.
Resistance band based exercise performed twice per week (2 x 1hr).
Aerobic stationary cycling based exercise performed twice per week (2 x 1hr).
|
Polyphenol Rich-Extract (Phyto-P) derived from Lactuca Sativa (red leaf lettuce).
12-Week daily consumption of 3g of Phyto-P (polyphenol-rich extract: chlorogenic acid (30.15 mg), chicoric acid (13.44 mg), 3,4-dicaffeoylquinic acid (8.43 mg), quercetin-3-O-glucoside (15.81 mg), quercetin-3-O-malonyl glucoside (33.00 mg), and anthocyanins (30.57
mg)) as capsules.
Resistance Band-Based Exercise: Participants will complete a dynamic warm up followed by eight exercises (squats, hip extensions, rows, chest press, split squats, calf raises, bicep curls, tricep extensions) each session, organized as four supersets of two exercises targeting both upper and lower body. Each exercise will be performed with a controlled three-second eccentric phase, with sets and repetitions gradually progressing from 2 × 8-12 to 3 × 12-14. Resistance will be increased using band color (thickness), and post-set Rate of Perceived Exertion (RPE) will guide individualized progression. Sessions will be conducted twice weekly for approximately 50 minutes. Aerobic Stationary Cycling: Participants will perform stationary cycling twice weekly for approximately 50 minutes per session at 60% of peak work rate (WRpeak). Exercise intensity will be re-prescribed after mid-point testing to ensure continued progression and alignment with participants' current fitness level |
|
Placebo Comparator: Placebo Control + Exercise
12-Week Daily consumption of 3g of maltodextrin taken as capsules starting the first day of 12 weeks of exercise.
Supervised group resistance and aerobic exercise performed 4x/week.
Resistance band based exercise performed twice per week (2 x 1hr).
Aerobic stationary cycling based exercise performed twice per week (2 x 1hr).
|
Resistance Band-Based Exercise: Participants will complete a dynamic warm up followed by eight exercises (squats, hip extensions, rows, chest press, split squats, calf raises, bicep curls, tricep extensions) each session, organized as four supersets of two exercises targeting both upper and lower body. Each exercise will be performed with a controlled three-second eccentric phase, with sets and repetitions gradually progressing from 2 × 8-12 to 3 × 12-14. Resistance will be increased using band color (thickness), and post-set Rate of Perceived Exertion (RPE) will guide individualized progression. Sessions will be conducted twice weekly for approximately 50 minutes. Aerobic Stationary Cycling: Participants will perform stationary cycling twice weekly for approximately 50 minutes per session at 60% of peak work rate (WRpeak). Exercise intensity will be re-prescribed after mid-point testing to ensure continued progression and alignment with participants' current fitness level
12-Week Daily consumption of 3g of maltodextrin consumed as capsules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Retention
Time Frame: 18 months, 12 weeks
|
Retention is expressed as the percentage of participants who completed baseline testing, the 12-week intervention, and post-testing visits, relative to those who completed baseline testing but did not finish.
Success is defined as at least 75% (≥30 of 40) completing the study while maintaining adherence above 75% for both exercise sessions and supplementation.
|
18 months, 12 weeks
|
|
Feasibility of Recruitment
Time Frame: 18 months
|
Number of participants recruited.
Success is defined as recruitment of 40 participants across 18 months.
|
18 months
|
|
Leg Extensor Strength
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in leg-extensor peak torque measured by isometric dynamometry in Newton meters (Nm).
|
-1 week, 6 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leg Exetensor Power
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in leg-extensor isotonic power measured by dynamometry in Newton meters (Nm).
|
-1 week, 6 weeks, 12 weeks
|
|
Handgrip Strength
Time Frame: week -1, week 6, week 12
|
Change in maximal handgrip strength measured using a dynamometer, expressed in kilograms (kg), with higher values indicating greater muscular strength.
|
week -1, week 6, week 12
|
|
Aerobic Capacity
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in peak wattage during a work rate max test measured on a cycle ergometer.
|
-1 week, 6 weeks, 12 weeks
|
|
Physical Function 30-Second Sit-to-Stand Test
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in number of repetitions completed in 30 seconds.
|
-1 week, 6 weeks, 12 weeks
|
|
Physical Function Short Performance Physical Battery
Time Frame: Time Frame: -1 week, 12 weeks
|
Change in total score across the three tests.
The Short Performance Physical Battery (SPPB) is assessment of lower-extremity function in older adults, comprising balance, gait speed, and chair stand tests.
Scores range from 0 to 12, with higher scores indicating better physical performance and mobility.
|
Time Frame: -1 week, 12 weeks
|
|
Physical Function Stair Climb Test
Time Frame: week -1, week 12
|
Change in the average time taken to complete a 10-step stair climb expressed in seconds (s).
|
week -1, week 12
|
|
Physical Function Functional Forward Reach Test
Time Frame: week -1, week 12
|
Change in average forward reach distance for each arm expressed in centimeteres (cm).
|
week -1, week 12
|
|
Mitochondrial respiration
Time Frame: -1 week, 12 weeks
|
Change in mitochondrial respiration measured by high resolution respirometry (Oroboros Oxygraph-2k).
|
-1 week, 12 weeks
|
|
Frailty
Time Frame: -1 week, 6 weeks, and 12 weeks
|
Change in Canadian Longitudinal Study on Aging (CLSA) Frailty Index Score.
The Canadian Longitudinal Study on Aging Frailty Index is a continuous measure from 0 to 1 calculated by dividing the number of health deficits present by the total number assessed, with higher values reflecting greater frailty.
It is derived from a self-reported questionnaire covering 52 items, with each item representing a potential deficit.
|
-1 week, 6 weeks, and 12 weeks
|
|
Well-Being
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in World Health Organization Five Well-Being Index Score (WHO-5).
The World Health Organization Five Well-Being Index (WHO-5) is a self-reported questionnaire consisting of 5 items assessing subjective well-being.
Each item is scored from 0 to 5, with total scores summed to a range of 0 to 25, where higher scores indicate better well-being.
|
-1 week, 6 weeks, 12 weeks
|
|
Anthropometrics Body Height
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in body height expressed in centimeters (cm).
|
-1 week, 6 weeks, 12 weeks
|
|
Anthropometrics Body Weight
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in body weight measured in kilograms (kg).
|
-1 week, 6 weeks, 12 weeks
|
|
Body Composition Fat Free Mass
Time Frame: -1 week, 6 weeks, 12 weeks
|
Change in bioelectrical impedance analysis (BIA) estimated fat free mass measured in kilograms (kg).
|
-1 week, 6 weeks, 12 weeks
|
|
Body Composition Body Fat Percentage
Time Frame: week -1, week 6, week 12
|
Change in bioelectrical impedance analysis (BIA) estimated body fat percentage.
|
week -1, week 6, week 12
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6044340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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