Enhancing Adaptations to Exercise

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03350906

Enrollment

Registered

2017-11-22

Start date

2018-01-01

Completion date

2021-12-31

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Exercise, muscle function

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.

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.

Interventions

DRUGn3-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).

DRUGPlacebo

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

PROCEDUREBiopsy

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.

DIAGNOSTIC_TESTBody Composition Scan

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Maximum Workload Muscle Strength	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.
Body Mass Index (BMI)	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
Body Fat	baseline, 6 months	Dexa Scan based body fat, measured as a percentage of body weight
Lean Body Mass	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

Measure	Time frame	Description
Erythrocyte Sedimentation Rate (ESR)	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
Weight	baseline, 6 months	Subjects calculated weight in kilograms
C-Reactive Protein (CRP)	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. n3-PUFA: The DHA/EPA softgels contained \ 465mg of EPA and \ 375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\ 381 mg) and poloxamer 237, NF (\ 8.8 mg). Biopsy: Two muscle biopsies from the upper part of one leg. A small (\ 1cm) incision was made through the skin, and a needle was used to remove the muscle.	30
Placebo Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. Placebo: Looks exactly like the study drug but contained soybean oil with no active ingredient. Biopsy: Two muscle biopsies from the upper part of one leg. A small (\ 1cm) incision was made through the skin, and a needle was used to remove the muscle.	33
Total	63

Baseline characteristics

Characteristic	Placebo	Total	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)
Age, Continuous	71.5 years STANDARD_DEVIATION 4.8	71.45 years STANDARD_DEVIATION 4.6	71.4 years STANDARD_DEVIATION 4.5
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	33 participants	63 participants	30 participants
Sex: Female, Male Female	20 Participants	34 Participants	14 Participants
Sex: Female, Male Male	13 Participants	29 Participants	16 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 33
other Total, other adverse events	0 / 30	0 / 33
serious Total, serious adverse events	0 / 30	0 / 33