Enhancing Adaptations to Exercise

NCT03350906 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 17-004403R01AG054454UL1RR024150
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Inflammation

Keywords

Exercise; muscle function

Outcome Measures

Primary Outcomes (4)

• Change in Maximum Workload Muscle Strength

  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.

  baseline, 6 months

• Body Mass Index (BMI)

  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

  baseline, 6 months

• Body Fat

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

  baseline, 6 months

• Lean Body Mass

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

  baseline, 6 months

Secondary Outcomes (3)

• C-Reactive Protein (CRP)

  baseline, 6 months

• Erythrocyte Sedimentation Rate (ESR)

  baseline, 6 months

• Weight

  baseline, 6 months

Study Arms (2)

n3-PUFA

EXPERIMENTAL

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.

Drug: n3-PUFA; Procedure: Biopsy; Diagnostic Test: Body Composition Scan

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Procedure: Biopsy; Diagnostic Test: Body Composition Scan

Interventions

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).

n3-PUFA

Placebo DRUG

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

Placebo

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.

Placebo; n3-PUFA

Body Composition Scan DIAGNOSTIC_TEST

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

Also known as: DEXA (dual-energy X-ray absorptiometry) scan.

Placebo; n3-PUFA

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Moosavi D, Vuckovic I, Kunz HE, Lanza IR. Metabolomic response to acute resistance exercise in healthy older adults by 1H-NMR. PLoS One. 2024 Mar 28;19(3):e0301037. doi: 10.1371/journal.pone.0301037. eCollection 2024.

  PMID: 38547208 DERIVED

• Moosavi D, Vuckovic I, Kunz HE, Lanza IR. A Randomized Trial of omega-3 Fatty Acid Supplementation and Circulating Lipoprotein Subclasses in Healthy Older Adults. J Nutr. 2022 Jul 6;152(7):1675-1689. doi: 10.1093/jn/nxac084.

  PMID: 35389487 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Inflammation; Motor Activity

Interventions

Docosahexaenoic Acids; Biopsy; Absorptiometry, Photon; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Ian R. Lanza, Ph.D.
• Organization: Mayo Clinic

Lanza.Ian@mayo.edu

507-255-8147

Study Officials

• Ian R Lanza, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 22, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 14, 2023
• Results First Posted: November 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)