Effects of Omega-3 Fatty Acid Supplementation and Physical Training on Metabolic Health

NCT06533891 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-25

No results posted yet for this study

Summary

The degree of insulin resistance in an individual can be monitored by several means including blood concentrations of insulin, triglycerides, HDL-C, and eventually glucose. In particular, the ratio of triglycerides to HDL-C reflects the severity of insulin resistance's impact on liver-mediated lipoprotein transport and may be a sensitive measure of early insulin resistance when fasting glucose levels are still in the normal range (compensated by higher output of insulin). High triglycerides and low HDL-C indicate poor metabolic health and increased risk of fatty liver and atherosclerotic cardiovascular diseases.

Two diet and lifestyle strategies that have shown therapeutic promise are 1) supplementation with omega-3 fatty acids and 2) aerobic exercise training. Omega-3 fatty acids can prevent the development of insulin resistance but have not been successful in reversing established insulin resistance. Importantly, omega-3 fatty acids are effective for improving the ratio of triglycerides to HDL-C in blood and reducing the amount of fat in the liver. Aerobic exercise has demonstrated greater success for reversing established insulin resistance, but it is not known if and to what degree supplementation with omega-3 fatty acids could potentiate its therapeutic efficacy and vice versa regarding dyslipidemia. Both omega-3 fatty acids and exercise lead to increased blood concentrations of beneficial oxygenated lipid compounds (termed oxylipins) that regulate inflammatory and metabolic processes (including insulin resistance) linked to the development of NAFL.

In preparation for studies of people in poorer metabolic health, the investigators will conduct a pilot and feasibility study of relatively inactive younger adults with low dietary intake of omega-3 fatty acids to assess whether increased aerobic physical activity combined with omega-3 supplementation leads to greater improvements in blood concentrations of triglycerides, HDL-C, and their ratio, as well as concentrations of oxylipins in the blood. The investigators will also assess whether a less studied omega-3 fatty acid, called DPA, may have effects above and beyond those conferred by EPA and DHA (which are concentrated in prescription omega-3 fatty acid products).

Conditions

Interventions

DIETARY_SUPPLEMENT

DPA enriched n-3

4 g/d DPA enriched n-3 concentrate (\~980 mg DPA, 380 mg EPA, 1720 mg DHA)

DIETARY_SUPPLEMENT

n-3 control

4 g/d n-3 control (\~980 oleic acid, 380 mg EPA, 1720 mg DHA)

DIETARY_SUPPLEMENT

Placebo

4 g/d placebo control ("light" olive oil)

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2020-05-31
Completion
2021-05-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533891 on ClinicalTrials.gov