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

NCT06533891 | Withdrawn

• 1 other identifier: 1912251764
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Triglyceride/HDL-C ratio

  Triglyceride/HDL-C ratio

  6 weeks

Other Outcomes (8)

• Oxylipins

  6 weeks

• Glucose

  6 weeks

• C-reactive protein (CRP)

  6 weeks

Study Arms (3)

DPA enriched n-3

EXPERIMENTAL

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

Dietary Supplement: DPA enriched n-3

n-3 control

ACTIVE COMPARATOR

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

Dietary Supplement: n-3 control

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

DPA enriched n-3 DIETARY_SUPPLEMENT

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

DPA enriched n-3

n-3 control DIETARY_SUPPLEMENT

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

n-3 control

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Light to moderate activity level
• BMI of 18-29 kg/m2
• Consistent dosage for any medication/supplements taken for inflammatory conditions
• Ability to abstain from alcohol for 48 hours prior to lab testing
• Low fish consumption (\<2 serving/week), no use of omega-3 or fish oil supplements

You may not qualify if:

• Pregnant or lactating
• Use of medications for blood thinning, elevated lipids, blood pressure, or glucose
• Allergy to fish
• Any condition for which exercise is contraindicated
• Intolerance to physical training

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: August 1, 2024
• Study Start: February 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2021
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share