Muscle Health and Recovery in Older Adults

Muscle Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205537
• Other study ID #: BL78
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Abbott Nutrition
• Contact: Kristen DeLuca
• Phone: 16145653522
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Muscle Injury

Intervention

Other:
• Control Liquid Supplement
Ready to drink supplement.
• Experimental Liquid Supplement
Ready to drink supplement.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Derby

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition	Changes in bioelectrical impedance analysis (BIA)	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Other	Muscle Biopsy Markers	Change in muscle biopsy markers	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Other	Saliva Biomarkers	Change in saliva biomarkers	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Other	Grip Strength	Change in hand grip dynamometer in kg	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Other	Microbiome	Change in Alpha and Beta diversity	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Other	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)
Other	Immunity Questionnaire	Participant reported information related to common cold symptoms	Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Other	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)
Other	Muscle Architecture	Changes in ultrasound measurements	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Primary	Leg Strength	Change in Peak torque of maximum voluntary contraction (MVC)	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Secondary	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)
Secondary	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)
Secondary	Leg Strength Changes	Change in Peak torque of maximum voluntary contraction (MVC)	Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
Secondary	Muscle Protein Synthesis	Change in Fractional Synthesis Rate	Post Exercise Day 1 to Day 7
Secondary	Muscle Protein Breakdown	Change in D3-3methylhistidine (D3-3MH)	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Secondary	Neuromuscular Function	Change in Electromyography	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Secondary	Blood Biomarker Muscle Damage	Changes in blood biomarker of muscle damage	Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Secondary	Blood Biomarker Oxidative Stress	Changes in blood biomarker of oxidative stress	Baseline up to Post Exercise Study Day 7 (up to 5 weeks)