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

Abbott Nutrition1 site in 1 country30 target enrollmentMay 20, 2024

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Abbott Nutrition
Enrollment: 30
Locations: 1
Primary Endpoint: Leg Strength
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 20, 2024

End Date

August 19, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Leg Strength Changes(Baseline to Day -1 Pre-Exercise (up to 4 Weeks))
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))
Muscle Protein Breakdown(Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days))
Neuromuscular Function(Baseline up to Post Exercise Study Day 7 (up to 5 weeks))
Blood Biomarker Muscle Damage(Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days))
Muscle Protein Synthesis(Post Exercise Day 1 to Day 7)
Blood Biomarker Oxidative Stress(Baseline up to Post Exercise Study Day 7 (up to 5 weeks))