Trial Outcomes & Findings for Enhancing Adaptations to Exercise (NCT NCT03350906)

NCT ID: NCT03350906

Last Updated: 2023-11-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 63 participants
• Primary outcome timeframe: baseline, 6 months
• Results posted on: 2023-11-14

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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.	Placebo n=33 Participants 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.	Total n=63 Participants Total of all reporting groups
Age, Continuous	71.4 years STANDARD_DEVIATION 4.5 • n=30 Participants	71.5 years STANDARD_DEVIATION 4.8 • n=33 Participants	71.45 years STANDARD_DEVIATION 4.6 • n=63 Participants
Sex: Female, Male Female	14 Participants n=30 Participants	20 Participants n=33 Participants	34 Participants n=63 Participants
Sex: Female, Male Male	16 Participants n=30 Participants	13 Participants n=33 Participants	29 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	33 participants n=33 Participants	63 participants n=63 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Change in Maximum Workload Muscle Strength	7.5 pounds Standard Deviation 14.1	3.1 pounds Standard Deviation 14.7

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Body Mass Index (BMI) Baseline	27.1 kg/m^2 Standard Deviation 4.0	26.3 kg/m^2 Standard Deviation 3.9
Body Mass Index (BMI) 6 months	27.2 kg/m^2 Standard Deviation 4.3	26.3 kg/m^2 Standard Deviation 3.8

PRIMARY outcome

Timeframe: baseline, 6 months

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

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Body Fat baseline	36.9 percentage of body weight Standard Deviation 7.3	35.8 percentage of body weight Standard Deviation 8.9
Body Fat 6 months	36.7 percentage of body weight Standard Deviation 7.2	35.8 percentage of body weight Standard Deviation 9.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Lean Body Mass baseline	46.0 kilograms Standard Deviation 8.0	45.5 kilograms Standard Deviation 10.6
Lean Body Mass 6 months	46.1 kilograms Standard Deviation 8.1	45.5 kilograms Standard Deviation 10.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
C-Reactive Protein (CRP) baseline	1.7 mg/L Standard Deviation 1.8	1.6 mg/L Standard Deviation 1.3
C-Reactive Protein (CRP) 6 months	1.5 mg/L Standard Deviation 1.9	2.2 mg/L Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Erythrocyte Sedimentation Rate (ESR) Baseline	7.8 mm/hr Standard Deviation 6.2	8.8 mm/hr Standard Deviation 6.5
Erythrocyte Sedimentation Rate (ESR) 6 months	7.5 mm/hr Standard Deviation 6.2	10.1 mm/hr Standard Deviation 9.3

SECONDARY outcome

Timeframe: baseline, 6 months

Subjects calculated weight in kilograms

Outcome measures

Measure	n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) n=30 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.	Placebo n=33 Participants 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. Body Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Weight baseline	77.3 kg Standard Deviation 13.1	74.5 kg Standard Deviation 14.5
Weight 6 months	77.1 kg Standard Deviation 13.6	74.5 kg Standard Deviation 14.5

Adverse Events

n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian R. Lanza, Ph.D.

Mayo Clinic

Phone: 507-255-8147

Email: Lanza.Ian@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place