Muscle Health and Recovery in Older Adults

Effects of Nutritional Ingredients on Muscle Health and Recovery Following a Short Bout of Exhaustive Exercise 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.

Study Overview

• Status: Completed
• Conditions: Exercise Induced Muscle Damage
• Intervention / Treatment: Other: Control Liquid Supplement; Other: Experimental Liquid Supplement

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3DT
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Oral Liquid Supplement (ONS) Group A; One 8 oz. serving	Other: Control Liquid Supplement; Ready to drink supplement.
Experimental: Oral Liquid Supplement (ONS) Group B; One 8 oz. serving	Other: Experimental Liquid Supplement; Ready to drink supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg Strength	Change in Peak torque of maximum voluntary contraction (MVC)	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Fatigue	Time to failure during a sub-maximal isometric contraction of the knee extensors	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Muscle Soreness	100 mm visual analog scale from No Pain to Extreme Pain	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Leg Strength Changes	Change in Peak torque of maximum voluntary contraction (MVC)	Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
Muscle Protein Synthesis	Change in Fractional Synthesis Rate	Post Exercise Day 1 to Day 7
Muscle Protein Breakdown	Change in D3-3methylhistidine (D3-3MH)	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Neuromuscular Function	Change in Electromyography	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Blood Biomarker Muscle Damage	Changes in blood biomarker of muscle damage	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Blood Biomarker Oxidative Stress	Changes in blood biomarker of oxidative stress	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition	Changes in bioelectrical impedance analysis (BIA)	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Muscle Biopsy Markers	Change in muscle biopsy markers	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Saliva Biomarkers	Change in saliva biomarkers	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Grip Strength	Change in hand grip dynamometer in kg	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Microbiome	Change in Alpha and Beta diversity	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Short Physical Performance Battery (SPPB) Score	Change in 3 domains to assess functional mobility; Scores from 0 to 12 with higher scores indicating better mobility	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Immunity Questionnaire	Participant reported information related to common cold symptoms	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Quality of Life - Short Form 36	Participant completed 36-item health survey resulting in a score from 0 to 100 where higher scores indicate better health status	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Muscle Architecture	Changes in ultrasound measurements	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Suzette Pereira, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): August 19, 2025
• Study Completion (Actual): August 19, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BL78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No