Improving 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 study is testing if a special nutritional supplement can help healthy older adults recover better from exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Sponsor | Abbott Nutrition Industry-sponsored |
| Locations | 1 site (Derby) |
| Trial ID | NCT06205537 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combination of nutritional ingredients on muscle health and recovery following exhaustive exercise in healthy older adults. It is a prospective, randomized, placebo-controlled, double-blinded trial, meaning participants will be assigned to either an experimental or control group without knowing which they receive. The study aims to determine if the nutritional supplement can enhance muscle recovery in individuals aged 60 to 75. Participants will refrain from starting any new exercise programs during the trial to ensure consistent results.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 60 to 75 with a BMI between 18.5 and 30 who are ambulatory and willing to follow the study protocol.
Not a fit: Patients with diabetes, recent major surgeries, or those who engage in strenuous exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle recovery strategies for older adults, enhancing their overall health and quality of life.
How similar studies have performed: Other studies have shown promise in using nutritional interventions for muscle recovery, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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 * 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).
Where this trial is running
Derby
- University of Nottingham — Derby, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Kristen DeLuca
- Email: kristen.deluca@abbott.com
- Phone: 16145653522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.