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Enhancing Adaptations to Exercise

NCT03350906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-11-14

Study results available
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Summary

Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.

Conditions

Interventions

DRUG

n3-PUFA

The DHA/EPA softgels will each contain \~465mg of EPA and \~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\~381 mg) and poloxamer 237, NF (\~8.8 mg).

DRUG

Placebo

Looks exactly like the study drug but contains soybean oil with no active ingredient.

PROCEDURE

Biopsy

Two muscle biopsies from the upper part of one leg. A small (\~1cm) incision will be made through the skin, and a needle will then be used to remove the muscle.

DIAGNOSTIC_TEST

Body Composition Scan

Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Ian R Lanza, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350906 on ClinicalTrials.gov