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SarcopeniaNCT07441343

Effects of Polyphenol Supplementation and Exercise on Physical Performance in Older Adults

A study testing Polyphenol Rich-Extract and Resistance Band-Based & Aerobic Stationary Cycling Exercise in people with Sarcopenia and Aging, run by Dr. Chris McGlory, PhD at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Aging, Frailty
What is being tested?
Polyphenol Rich-Extract and Resistance Band-Based & Aerobic Stationary Cycling Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
1 Sep 2025to 8 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female or Male
  • Age > 60y
  • Non-Smoking
  • English Speaking

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Queen's University School of Kinesiology & Health Studies

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Polyphenol Rich-Extract, Maltodextrin (Placebo), Resistance Band-Based & Aerobic Stationary Cycling Exercise
Keywords
Polyphenol, Resistance training, Aerobic exercise, sarcopenia, older adults, skeletal muscle
Medical subject headings
Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyphenol Rich-ExtractDietary supplement

    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.

  • Maltodextrin (Placebo)Dietary supplement

    12-Week Daily consumption of 3g of maltodextrin consumed as capsules.

  • Resistance Band-Based & Aerobic Stationary Cycling ExerciseBehavioural

    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

Study groups in NCT07441343
Study groupRoleWhat they receive
Polyphenol Supplement + ExerciseExperimental12-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).
Receives: Dietary Supplement: Polyphenol Rich-Extract; Behavioral: Resistance Band-Based & Aerobic Stationary Cycling Exercise
Placebo Control + ExercisePlacebo comparator12-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).
Receives: Dietary Supplement: Maltodextrin (Placebo); Behavioral: Resistance Band-Based & Aerobic Stationary Cycling Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Retention

    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.

    Measured: 18 months, 12 weeks

  2. Feasibility of Recruitment

    Number of participants recruited. Success is defined as recruitment of 40 participants across 18 months.

    Measured: 18 months

  3. Leg Extensor Strength

    Change in leg-extensor peak torque measured by isometric dynamometry in Newton meters (Nm).

    Measured: -1 week, 6 weeks, 12 weeks

Secondary outcomes (14)
  1. Leg Exetensor Power

    Change in leg-extensor isotonic power measured by dynamometry in Newton meters (Nm).

    Measured: -1 week, 6 weeks, 12 weeks

  2. Handgrip Strength

    Change in maximal handgrip strength measured using a dynamometer, expressed in kilograms (kg), with higher values indicating greater muscular strength.

    Measured: week -1, week 6, week 12

  3. Aerobic Capacity

    Change in peak wattage during a work rate max test measured on a cycle ergometer.

    Measured: -1 week, 6 weeks, 12 weeks

  4. Physical Function 30-Second Sit-to-Stand Test

    Change in number of repetitions completed in 30 seconds.

    Measured: -1 week, 6 weeks, 12 weeks

  5. Physical Function Short Performance Physical Battery

    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.

    Measured: Time Frame: -1 week, 12 weeks

  6. Physical Function Stair Climb Test

    Change in the average time taken to complete a 10-step stair climb expressed in seconds (s).

    Measured: week -1, week 12

  7. Physical Function Functional Forward Reach Test

    Change in average forward reach distance for each arm expressed in centimeteres (cm).

    Measured: week -1, week 12

  8. Mitochondrial respiration

    Change in mitochondrial respiration measured by high resolution respirometry (Oroboros Oxygraph-2k).

    Measured: -1 week, 12 weeks

  9. Frailty

    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.

    Measured: -1 week, 6 weeks, and 12 weeks

  10. Well-Being

    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.

    Measured: -1 week, 6 weeks, 12 weeks

  11. Anthropometrics Body Height

    Change in body height expressed in centimeters (cm).

    Measured: -1 week, 6 weeks, 12 weeks

  12. Anthropometrics Body Weight

    Change in body weight measured in kilograms (kg).

    Measured: -1 week, 6 weeks, 12 weeks

  13. Body Composition Fat Free Mass

    Change in bioelectrical impedance analysis (BIA) estimated fat free mass measured in kilograms (kg).

    Measured: -1 week, 6 weeks, 12 weeks

  14. Body Composition Body Fat Percentage

    Change in bioelectrical impedance analysis (BIA) estimated body fat percentage.

    Measured: week -1, week 6, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Sep 2025
  3. Primary completion8 Jun 2026
  4. Study completion8 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled feasibility trial. Two-armed. Half of the participants will be allocated to the nutritional intervention (20), and half to the placebo control condition (20).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441343
Sponsor's protocol ID
6044340
Status last verified
Aug 2026
First submitted
5 Feb 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Polyphenol Rich-Extract and Resistance Band-Based & Aerobic Stationary Cycling Exercise in people with Sarcopenia and Aging, run by Dr. Chris McGlory, PhD at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Retention (time frame: 18 months, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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