Muscle Health and Recovery in Older Adults

NCT06205537 | Completed

• 1 other identifier: BL78
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exercise Induced Muscle Damage

Outcome Measures

Primary Outcomes (1)

• Leg Strength

  Change in Peak torque of maximum voluntary contraction (MVC)

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

Secondary Outcomes (8)

• Muscle Fatigue

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

• Muscle Soreness

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

• Leg Strength Changes

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

• Muscle Protein Synthesis

  Post Exercise Day 1 to Day 7

• Muscle Protein Breakdown

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

Other Outcomes (9)

• Body Composition

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

• Muscle Biopsy Markers

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

• Saliva Biomarkers

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

Study Arms (2)

Oral Liquid Supplement (ONS) Group A

PLACEBO COMPARATOR

One 8 oz. serving

Other: Control Liquid Supplement

Oral Liquid Supplement (ONS) Group B

EXPERIMENTAL

One 8 oz. serving

Other: Experimental Liquid Supplement

Interventions

Control Liquid Supplement OTHER

Ready to drink supplement.

Oral Liquid Supplement (ONS) Group A

Experimental Liquid Supplement OTHER

Ready to drink supplement.

Oral Liquid Supplement (ONS) Group B

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

University of Nottingham

Derby, DE22 3DT, United Kingdom

Location

Study Officials

• Suzette Pereira

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: May 20, 2024
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)