Exercise Induced Muscle Damage
Conditions
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.
Interventions
OTHERControl Liquid Supplement
Ready to drink supplement.
OTHERExperimental Liquid Supplement
Ready to drink supplement.
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Strength | Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days) | Change in Peak torque of maximum voluntary contraction (MVC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Fatigue | 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 |
| Muscle Soreness | Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days) | 100 mm visual analog scale from No Pain to Extreme Pain |
| Leg Strength Changes | Baseline to Day -1 Pre-Exercise (up to 4 Weeks) | Change in Peak torque of maximum voluntary contraction (MVC) |
| Muscle Protein Synthesis | Post Exercise Day 1 to Day 7 | Change in Fractional Synthesis Rate |
| Muscle Protein Breakdown | Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days) | Change in D3-3methylhistidine (D3-3MH) |
| Neuromuscular Function | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Change in Electromyography |
| Blood Biomarker Muscle Damage | Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days) | Changes in blood biomarker of muscle damage |
| Blood Biomarker Oxidative Stress | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Changes in blood biomarker of oxidative stress |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Changes in bioelectrical impedance analysis (BIA) |
| Muscle Biopsy Markers | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Change in muscle biopsy markers |
| Saliva Biomarkers | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Change in saliva biomarkers |
| Grip Strength | Baseline to Pre-Exercise Study Day -1 (up to 4 weeks) | Change in hand grip dynamometer in kg |
| Microbiome | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Change in Alpha and Beta diversity |
| Short Physical Performance Battery (SPPB) Score | 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 |
| Immunity Questionnaire | Baseline to Pre-Exercise Study Day -1 (up to 4 weeks) | Participant reported information related to common cold symptoms |
| Quality of Life - Short Form 36 | 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 |
| Muscle Architecture | Baseline up to Post Exercise Study Day 7 (up to 5 weeks) | Changes in ultrasound measurements |
Countries
United Kingdom
Outcome results
None listed