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Completed

NCT Number: NCT03350906

Enhancing Adaptations to Exercise

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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Key information

Conditions

Inflammation Behavior Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n3-PUFA

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).

Placebo

Drug

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

Biopsy

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

Diagnostic Test

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

Other names: DEXA (dual-energy X-ray absorptiometry) scan.

Primary outcomes

  1. Change in Maximum Workload Muscle Strength

    Time frame: baseline, 6 months

    Single-leg knee extensor strength was measured on a pneumatic resistance leg extension machine (Keiser Air300, Keiser Corporation, Fresno, CA, USA) and defined as the unilateral 1-repetition maximum (1-RM). Subjects performed a unilateral knee extension warm-up consisting of 10 repetitions at minimal resistance and 3 sets of 5-10 repetitions at increasing workloads. Subjects then performed a series of single repetition attempts at increasing workloads, each separated by 3 min of rest, until the maximum load that could be moved through the entire range of motion was reached. This maximum workload was defined as the individual 1-RM.

  2. Body Mass Index (BMI)

    Time frame: baseline, 6 months

    Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions). Measured as kg/m^2

  3. Body Fat

    Time frame: baseline, 6 months

    Dexa Scan based body fat, measured as a percentage of body weight

  4. Lean Body Mass

    Time frame: baseline, 6 months

    Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms.

Secondary outcomes

  1. C-Reactive Protein (CRP)

    Time frame: baseline, 6 months

    C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L

  2. Erythrocyte Sedimentation Rate (ESR)

    Time frame: baseline, 6 months

    ESR is a blood test that can reveal inflammatory activity in the body. It measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response of the immune system. Normal results: < 16 years: < 10 mm/hr;Male < 50 years: < 15 mm/hr;Male > 50 years: < 20 mm/hr;Female < 50 years: < 20 mm/hr;Female > 50 years: < 30 mm/hr

  3. Weight

    Time frame: baseline, 6 months

    Subjects calculated weight in kilograms

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2017
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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