Clinical trial NCT06205537: Muscle Health and Recovery in Older Adults
Official title: Effects of Nutritional Ingredients on Muscle Health and Recovery Following a Short Bout of Exhaustive Exercise in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Injury
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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).

Primary outcomes:
measure: Leg Strength
timeFrame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Secondary outcomes:
measure: Muscle Fatigue
timeFrame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
measure: Muscle Soreness
timeFrame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
measure: Leg Strength Changes
timeFrame: Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
measure: Muscle Protein Synthesis
timeFrame: Post Exercise Day 1 to Day 7
measure: Muscle Protein Breakdown
timeFrame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
measure: Neuromuscular Function
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
measure: Blood Biomarker Muscle Damage
timeFrame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
measure: Blood Biomarker Oxidative Stress
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Other outcomes:
measure: Body Composition
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
measure: Muscle Biopsy Markers
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
measure: Saliva Biomarkers
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
measure: Grip Strength
timeFrame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
measure: Microbiome
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
measure: Short Physical Performance Battery (SPPB) Score
timeFrame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
measure: Immunity Questionnaire
timeFrame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
measure: Quality of Life - Short Form 36
timeFrame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
measure: Muscle Architecture
timeFrame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Abbott Nutrition
name: Suzette Pereira
role: STUDY_CHAIR
References: