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InflammationPhase 3NCT03350906

Enhancing Adaptations to Exercise

A Phase 3 study testing n3-PUFA, Biopsy and Body Composition Scan in people with Inflammation, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Inflammation
What is being tested?
n3-PUFA, Biopsy and Body Composition Scan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to 31 Dec 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the detailed description

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
Inflammation
Being tested
n3-PUFA, Placebo, Biopsy, Body Composition Scan
Keywords
Exercise, muscle function
Medical subject headings
Inflammation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    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 ScanDiagnostic test

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

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

Study groups in NCT03350906
Study groupRoleWhat they receive
n3-PUFAExperimentalParticipants 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.
Receives: Drug: n3-PUFA; Procedure: Biopsy; Diagnostic Test: Body Composition Scan
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Procedure: Biopsy; Diagnostic Test: Body Composition Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 6 months

  2. 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

    Measured: baseline, 6 months

  3. Body Fat

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

    Measured: baseline, 6 months

  4. 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.

    Measured: baseline, 6 months

Secondary outcomes (3)

  1. C-Reactive Protein (CRP)

    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

    Measured: baseline, 6 months

  2. Erythrocyte Sedimentation Rate (ESR)

    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

    Measured: baseline, 6 months

  3. Weight

    Subjects calculated weight in kilograms

    Measured: baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350906
Sponsor's protocol ID
17-004403
Other IDs
R01AG054454, UL1RR024150
Status last verified
Oct 2023
First submitted
13 Nov 2017
Last updated
14 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38547208

  • 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.

    PubMed 35389487

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing n3-PUFA, Biopsy and Body Composition Scan in people with Inflammation, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maximum Workload Muscle Strength (time frame: baseline, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350906, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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