A Phase 3 interventional study of n3-PUFA and Placebo in Inflammation, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 63 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
Looks exactly like the study drug but contains soybean oil with no active ingredient.
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.
Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Also known as: DEXA (dual-energy X-ray absorptiometry) scan.
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.
Time frame: 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
Time frame: baseline, 6 months
Body Fat
Dexa Scan based body fat, measured as a percentage of body weight
Time frame: 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.
Time frame: baseline, 6 months
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
Time frame: baseline, 6 months
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
Time frame: baseline, 6 months
Weight
Subjects calculated weight in kilograms
Time frame: baseline, 6 months
| Milestone | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| Started | 30 | 33 |
| Completed | 30 | 33 |
| Not completed | 0 | 0 |
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.
| pounds | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| Change in Maximum Workload Muscle Strength | 7.5 ± 14.1 | 3.1 ± 14.7 |
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
| kg/m^2 | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| Baseline | 27.1 ± 4.0 | 26.3 ± 3.9 |
| 6 months | 27.2 ± 4.3 | 26.3 ± 3.8 |
Dexa Scan based body fat, measured as a percentage of body weight
| percentage of body weight | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| baseline | 36.9 ± 7.3 | 35.8 ± 8.9 |
| 6 months | 36.7 ± 7.2 | 35.8 ± 9.1 |
Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms.
| kilograms | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| baseline | 46.0 ± 8.0 | 45.5 ± 10.6 |
| 6 months | 46.1 ± 8.1 | 45.5 ± 10.5 |
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
| mg/L | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| baseline | 1.7 ± 1.8 | 1.6 ± 1.3 |
| 6 months | 1.5 ± 1.9 | 2.2 ± 2.5 |
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
| mm/hr | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| Baseline | 7.8 ± 6.2 | 8.8 ± 6.5 |
| 6 months | 7.5 ± 6.2 | 10.1 ± 9.3 |
Subjects calculated weight in kilograms
| kg | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo |
|---|---|---|
| baseline | 77.3 ± 13.1 | 74.5 ± 14.5 |
| 6 months | 77.1 ± 13.6 | 74.5 ± 14.5 |
Collected over Adverse events were collected from baseline to end of study, approximately 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Placebo | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo | Total |
|---|---|---|---|
| Mean | 71.4 ± 4.5 | 71.5 ± 4.8 | 71.45 ± 4.6 |
| Sex: Female, Male(Participants) | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo | Total |
|---|---|---|---|
| Female | 14 | 20 | 34 |
| Male | 16 | 13 | 29 |
| Race and Ethnicity Not Collected(Participants) | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Placebo | Total |
|---|---|---|---|
| United States | 30 | 33 | 63 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2021, 47 months.
Results were first posted in Nov 2023, 1 year 10 months after primary completion. A results delay was requested in Nov 2022.
Of 47 non-industry phase 3 interventional studies under Inflammation, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's 47 months is close to that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid