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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Liquid Supplement (ONS) Group A | Placebo Comparator | One 8 oz. serving |
|
| Oral Liquid Supplement (ONS) Group B | Experimental | One 8 oz. serving |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Liquid Supplement | Other | Ready to drink supplement. |
| |
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzette Pereira | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Derby | DE22 3DT | United Kingdom |
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| Experimental Liquid Supplement |
| Other |
Ready to drink supplement. |
|
| 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) |
| 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) |