Trial Outcomes & Findings for Fish Oil for HIV-Related Inflamm-aging and Immune Senescence (NCT NCT02102724)

NCT ID: NCT02102724

Last Updated: 2019-03-26

Results Overview

Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: End of 12-Week Supplementation Period
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Fish Oil Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Overall Study STARTED	18	19
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Fish Oil Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Overall Study Lost to Follow-up	1	0
Overall Study surgery for brain aneurysm	1	1

Baseline Characteristics

Fish Oil for HIV-Related Inflamm-aging and Immune Senescence

Baseline characteristics by cohort

Measure	Fish Oil n=18 Participants Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo n=19 Participants Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Total n=37 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 5.4 • n=5 Participants	53 years STANDARD_DEVIATION 6.1 • n=7 Participants	54 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: End of 12-Week Supplementation Period

Population: Wilcoxon rank sum tests for intergroup change scores

Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.

Outcome measures

Measure	Fish Oil n=18 Participants Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo n=19 Participants Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD4+ cells CD28-/CD57+	0.69 percentage of cells Interval -1.2 to 2.5	-2.41 percentage of cells Interval -9.6 to 4.8
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD4+ cells CD28+/CD57-	1.87 percentage of cells Interval -2.8 to 6.5	4.22 percentage of cells Interval -3.5 to 11.9
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD4+ cells CD28-/CD57-	-2.83 percentage of cells Interval -6.9 to 1.2	-1.56 percentage of cells Interval -3.0 to -0.08
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD8+ cells CD28+/CD57-	-1.58 percentage of cells Interval -10.8 to 7.7	-4.63 percentage of cells Interval -19.6 to 10.4
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD8+ cells CD28-/CD57-	-3.6 percentage of cells Interval -7.7 to 0.5	0.79 percentage of cells Interval -4.8 to 6.4
Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation Percent CD8+ cells CD28-/CD57+	-2.37 percentage of cells Interval -8.7 to 4.4	1.96 percentage of cells Interval -6.2 to 10.1

Adverse Events

Fish Oil

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fish Oil n=18 participants at risk Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo n=19 participants at risk Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Blood and lymphatic system disorders lymphoma	0.00% 0/18 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.	5.3% 1/19 • Number of events 1 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.
Nervous system disorders brain aneurysm	5.6% 1/18 • Number of events 1 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.	0.00% 0/19 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.

Other adverse events

Measure	Fish Oil n=18 participants at risk Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids	Placebo n=19 participants at risk Participants will receive 1 gram of oleic sunflower oil for 12 weeks. Fish oil that contains omega-3 fatty acids: Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Gastrointestinal disorders GI disturbance	44.4% 8/18 • Number of events 8 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.	21.1% 4/19 • Number of events 4 • Over the 12-week supplementation period Adverse event data were collected at baseline, week four and week 12.

Additional Information

Barbara Swanson

Rush University College of Nursing

Phone: 3129428977

Email: BARBARA_A_SWANSON@RUSH.EDU

Results disclosure agreements

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