Muscle Health and Recovery in Older Adults

Abbott

Status: Completed

Conditions: Exercise Induced Muscle Damage

Treatments: Other: Experimental Liquid Supplement; Other: Control Liquid Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06205537

BL78

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Oral Liquid Supplement (ONS) Group A

Placebo Comparator group

Description:

One 8 oz. serving

Treatment:

Other: Control Liquid Supplement

Oral Liquid Supplement (ONS) Group B

Experimental group

Description:

One 8 oz. serving

Treatment:

Other: Experimental Liquid Supplement