Enhancing Adaptations to Exercise

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Participants will be divided into two groups. Men and women between the ages of 20-35 years and 65-85 years. Participants in the older age group will be randomly assigned to receive groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the intervention, all participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention phase of the study, participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and return any remaining capsules from the previous prescription. On the day they pick up prescription refills, participants will report to the CRTU for a fasting blood sample. The duration of the intervention will be 6 months.

Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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n3-PUFA

Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.

Group Type EXPERIMENTAL

n3-PUFA

Intervention Type DRUG

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).

Biopsy

Intervention Type PROCEDURE

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 Scan

Intervention Type DIAGNOSTIC_TEST

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

Placebo

Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Biopsy

Intervention Type PROCEDURE

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 Scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Body Composition Scan

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DEXA (dual-energy X-ray absorptiometry) scan.

Eligibility Criteria

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Inclusion Criteria

* Men and women between the ages of 20-35 years
* Men and women between the ages of 65-85 years

Exclusion Criteria

* Regular use of omega-3 nutritional supplements
* Diabetes or fasting plasma glucose \> or equal to 126 mg/dL
* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (AST\>144 IU/L or ALT\>165 IU/L)
* Oral warfarin group medications or history of blood clotting disorders.
* international normalized ratio (INR) \>2.01.5
* Smoking
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled hypothyroidism
* Debilitating chronic disease (at the discretion of the investigators)
* Fish or shellfish allergy

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes