Skip to main content
OpenTrials
Completed

NCT Number: NCT06205537

Muscle Health and Recovery in Older Adults

This is a prospective, randomized, placebo controlled, double-blinded study to evaluate the efficacy of a combination of nutritional ingredients on muscle health and recovery from a short bout of exhaustive exercise in healthy older adults.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Derby, DE22 3DT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participant, male and female (≥60 and ≤75 years of age)
  • Subject is ambulatory
  • Body mass index (BMI) >18.5 but <30 kg/m2
  • Subject agrees to refrain from starting an exercise program throughout the trial
  • Has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and applicable privacy regulation authorization prior to any participation in the study
  • Willingness to follow the protocol as described, including consumption of study product per the protocol, and completing any forms/questionnaires needed throughout the study

Exclusion criteria

  • Subject reports having type 1 or type 2 diabetes
  • Subject reports having undergone major surgery that might affect the outcomes
  • Has stated presence of partial or full lower artificial limb
  • Is unable to participate in an exercise protocol
  • Habitually engages in strenuous exercise, duration of 1 hour or longer, 3 or more times per week
  • Subjects has received systemic corticosteroid treatment in the last 3 months
  • Subject reports recent oral antibiotic use
  • Subject reports of current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
  • Subject reports of significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure
  • Subject reports of end-stage organ failure or is post-organ transplant
  • Subject reports of current or history of renal disease or severe gastroparesis
  • Subject reports of current diagnosed hepatic disease
  • Subject reports of history of GI disease that could impact digestion or absorption of the study product
  • Subject reports a history of autoimmune or connective tissue diseases that may affect muscle.
  • Subject reports clotting or bleeding disorders.
  • Subject reports a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV.
  • Subjects reports an eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
  • Subject reports having statin-induced myopathy at time of screening.
  • Subject reports taking certain dietary supplements, oral nutritional supplements or high protein nutritional supplements, or medications, that could profoundly affect muscle metabolism. Exceptions for multi-vitamin/mineral supplement and inhaled steroids for asthma, topical or optical steroids. Those users who can stop using such products for ≥4 weeks before baseline visit and agree to refrain from taking them over the study period need not be excluded.
  • Subject cannot refrain from using specific oils in their home cooked meals over the course of the study.
  • Has an allergy or intolerance to any ingredient in the study product.
  • Participates in another study that has not been approved as a concomitant study by Abbott Nutrition.
  • Subject has participated in another research study in the last 3 months that involved an inconvenience allowance or biosampling (including >50ml blood or any tissue samples).

Treatment and study plan

Control Liquid Supplement

Other

Ready to drink supplement.

Experimental Liquid Supplement

Other

Ready to drink supplement.

Primary outcomes

  1. Leg Strength

    Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

    Change in Peak torque of maximum voluntary contraction (MVC)

Secondary outcomes

  1. Muscle Fatigue

    Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

    Time to failure during a sub-maximal isometric contraction of the knee extensors

  2. Muscle Soreness

    Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

    100 mm visual analog scale from No Pain to Extreme Pain

  3. Leg Strength Changes

    Time frame: Baseline to Day -1 Pre-Exercise (up to 4 Weeks)

    Change in Peak torque of maximum voluntary contraction (MVC)

  4. Muscle Protein Synthesis

    Time frame: Post Exercise Day 1 to Day 7

    Change in Fractional Synthesis Rate

  5. Muscle Protein Breakdown

    Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

    Change in D3-3methylhistidine (D3-3MH)

  6. Neuromuscular Function

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Change in Electromyography

  7. Blood Biomarker Muscle Damage

    Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

    Changes in blood biomarker of muscle damage

  8. Blood Biomarker Oxidative Stress

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Changes in blood biomarker of oxidative stress

Other outcomes

  1. Body Composition

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Changes in bioelectrical impedance analysis (BIA)

  2. Muscle Biopsy Markers

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Change in muscle biopsy markers

  3. Saliva Biomarkers

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Change in saliva biomarkers

  4. Grip Strength

    Time frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)

    Change in hand grip dynamometer in kg

  5. Microbiome

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Change in Alpha and Beta diversity

  6. Short Physical Performance Battery (SPPB) Score

    Time frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)

    Change in 3 domains to assess functional mobility; Scores from 0 to 12 with higher scores indicating better mobility

  7. Immunity Questionnaire

    Time frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)

    Participant reported information related to common cold symptoms

  8. Quality of Life - Short Form 36

    Time frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)

    Participant completed 36-item health survey resulting in a score from 0 to 100 where higher scores indicate better health status

  9. Muscle Architecture

    Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

    Changes in ultrasound measurements

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Effects of Nutritional Ingredients on Muscle Health and Recovery Following a Short Bout of Exhaustive Exercise in Older Adults

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.