Exercise Induced Muscle DamageNCT06205537
Muscle Health and Recovery in Older Adults
A study testing Experimental Liquid Supplement in people with Exercise Induced Muscle Damage, run by Abbott Nutrition at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage
- What is being tested?
- Experimental Liquid Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2024to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nutritional Ingredients on Muscle Health and Recovery Following a Short Bout of Exhaustive Exercise in Older Adults
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.
- Conditions
- Exercise Induced Muscle Damage
- Being tested
- Control Liquid Supplement, Experimental Liquid Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Liquid SupplementOther
Ready to drink supplement.
Experimental Liquid SupplementOther
Ready to drink supplement.
| Study group | Role | What they receive |
|---|---|---|
| Oral Liquid Supplement (ONS) Group A | Placebo comparator | One 8 oz. serving Receives: Other: Control Liquid Supplement |
| Oral Liquid Supplement (ONS) Group B | Experimental | One 8 oz. serving Receives: Other: Experimental Liquid Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Strength
Change in Peak torque of maximum voluntary contraction (MVC)
Measured: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Secondary outcomes (8)
Muscle Fatigue
Time to failure during a sub-maximal isometric contraction of the knee extensors
Measured: 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
Measured: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Leg Strength Changes
Change in Peak torque of maximum voluntary contraction (MVC)
Measured: Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
Muscle Protein Synthesis
Change in Fractional Synthesis Rate
Measured: Post Exercise Day 1 to Day 7
Muscle Protein Breakdown
Change in D3-3methylhistidine (D3-3MH)
Measured: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Neuromuscular Function
Change in Electromyography
Measured: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Blood Biomarker Muscle Damage
Changes in blood biomarker of muscle damage
Measured: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Blood Biomarker Oxidative Stress
Changes in blood biomarker of oxidative stress
Measured: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 May 2024
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzette Pereira, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205537
- Sponsor's protocol ID
- BL78
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Ingredients on Muscle Health and Recovery Following a Short Bout of Exhaustive Exercise in Older Adults
- ClinicalTrials.gov ID
- NCT06205537
- Acronym / sponsor ID
- BL78
- Conditions
- Exercise Induced Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Liquid Supplement (ONS) Group A | Placebo comparator | Other: Control Liquid SupplementOne 8 oz. serving |
| Oral Liquid Supplement (ONS) Group B | Experimental | Other: Experimental Liquid SupplementOne 8 oz. serving |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Liquid SupplementReady to drink supplement. | Other | Oral Liquid Supplement (ONS) Group A |
| Experimental Liquid SupplementReady to drink supplement. | Other | Oral Liquid Supplement (ONS) Group B |
Primary outcome
Leg Strength
Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Change in Peak torque of maximum voluntary contraction (MVC)
8 secondary outcomes
Muscle Fatigue
Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Muscle Soreness
Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Leg Strength Changes
Time frame: Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
Muscle Protein Synthesis
Time frame: Post Exercise Day 1 to Day 7
Muscle Protein Breakdown
Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Neuromuscular Function
Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Blood Biomarker Muscle Damage
Time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Blood Biomarker Oxidative Stress
Time frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzette Pereira study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Liquid Supplement in people with Exercise Induced Muscle Damage, run by Abbott Nutrition at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg Strength (time frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.