NCT07441343

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 5, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

PolyphenolResistance trainingAerobic exercisesarcopeniaolder adultsskeletal muscle

Outcome Measures

Primary Outcomes (3)

  • 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.

    18 months, 12 weeks

  • Feasibility of Recruitment

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

    18 months

  • Leg Extensor Strength

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

    -1 week, 6 weeks, 12 weeks

Secondary Outcomes (14)

  • Leg Exetensor Power

    -1 week, 6 weeks, 12 weeks

  • Handgrip Strength

    week -1, week 6, week 12

  • Aerobic Capacity

    -1 week, 6 weeks, 12 weeks

  • Physical Function 30-Second Sit-to-Stand Test

    -1 week, 6 weeks, 12 weeks

  • Physical Function Short Performance Physical Battery

    Time Frame: -1 week, 12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Polyphenol Supplement + Exercise

EXPERIMENTAL

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).

Dietary Supplement: Polyphenol Rich-ExtractBehavioral: Resistance Band-Based & Aerobic Stationary Cycling Exercise

Placebo Control + Exercise

PLACEBO COMPARATOR

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).

Dietary Supplement: Maltodextrin (Placebo)Behavioral: Resistance Band-Based & Aerobic Stationary Cycling Exercise

Interventions

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.

Polyphenol Supplement + Exercise
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

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

Placebo Control + Exercise

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 Control + ExercisePolyphenol Supplement + Exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University School of Kinesiology & Health Studies

Kingston, Ontario, K7L 3N6, Canada

RECRUITING

MeSH Terms

Conditions

SarcopeniaFrailty

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Central Study Contacts

Chris McGlory, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, School of Kinesiology and Health Studies, Dept. Medicine, Queen's University

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 27, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations