Muscle Health and Recovery in Older Adults

September 25, 2025 updated by: Abbott Nutrition

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE22 3DT
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Oral Liquid Supplement (ONS) Group A
One 8 oz. serving
Other: Control Liquid Supplement
Ready to drink supplement.
Experimental: Oral Liquid Supplement (ONS) Group B
One 8 oz. serving
Other: Experimental Liquid Supplement
Ready to drink supplement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle Fatigue
Time Frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
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
Time Frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
100 mm visual analog scale from No Pain to Extreme Pain
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)
Change in Peak torque of maximum voluntary contraction (MVC)
Baseline to Day -1 Pre-Exercise (up to 4 Weeks)
Muscle Protein Synthesis
Time Frame: Post Exercise Day 1 to Day 7
Change in Fractional Synthesis Rate
Post Exercise Day 1 to Day 7
Muscle Protein Breakdown
Time Frame: Pre-Exercise (Day -1) to Post Exercise Recovery (up to 7 Days)
Change in D3-3methylhistidine (D3-3MH)
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)
Change in Electromyography
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)
Changes in blood biomarker of muscle damage
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)
Changes in blood biomarker of oxidative stress
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Changes in bioelectrical impedance analysis (BIA)
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Muscle Biopsy Markers
Time Frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Change in muscle biopsy markers
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Saliva Biomarkers
Time Frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Change in saliva biomarkers
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Grip Strength
Time Frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Change in hand grip dynamometer in kg
Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
Microbiome
Time Frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Change in Alpha and Beta diversity
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Short Physical Performance Battery (SPPB) Score
Time Frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
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
Time Frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
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
Time Frame: Baseline to Pre-Exercise Study Day -1 (up to 4 weeks)
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
Time Frame: Baseline up to Post Exercise Study Day 7 (up to 5 weeks)
Changes in ultrasound measurements
Baseline up to Post Exercise Study Day 7 (up to 5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Suzette Pereira, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL78

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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