CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
n3-PUFA +3 moredrug
Likely dose
n3-PUFA 465mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03350906
NCT03350906Phase 3Completed

Enhancing Adaptations to Exercise

Mayo Clinic·interventional·Posted Nov 22, 2017·Updated Nov 14, 2023

In Brief

A Phase 3 clinical trial evaluating n3-PUFA, Placebo, and 2 other interventions for Inflammation. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartJan 1, 2018
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 8.6 years ago

Interventions

n3-PUFAdrug

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).

Placebodrug

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

Biopsyprocedure

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.

Body Composition Scanother

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