Overview

This trial is active, not recruiting.

Condition insulin resistance
Treatments omega-3, placebo
Phase phase 3
Sponsor Mayo Clinic
Start date December 2012
End date October 2014
Trial size 40 participants
Trial identifier NCT01686568, 12-004590

Summary

This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
omega-3 Essential fatty acids
Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
(Placebo Comparator)
Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
placebo

Primary Outcomes

Measure
Change from baseline in insulin sensitivity by hyperinsulinemic-euglycemic clamp
time frame: Baseline, after 6 months of treatment
Change from baseline in beta cell function following ingestion of a mixed meal
time frame: baseline, after 6 months of treatment

Secondary Outcomes

Measure
Change from baseline in mitochondrial function determined by muscle biopsy
time frame: Baseline, after 6 months of treatment
Change from baseline in muscle and liver lipid content
time frame: baseline, 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion criteria: 1. Age 18-65 years 2. Insulin resistant (HOMA IR ≥2.6) Exclusion criteria: 1. Current use of omega-3 nutritional supplements 2. Fasting plasma glucose ≥126 mg/dL 3. Active coronary artery disease 4. Participation in structured exercise (>2 times per week for 30 minutes or longer) 5. Smoking 6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants) 7. Renal failure (serum creatinine > 1.5mg/dl) 8. Chronic active liver disease (AST>144IU/L and ALT>165IU/L) 9. Anti-coagulant therapy (warfarin/heparin) 10. INR >3 11. Use of systemic glucocorticoids 12. Chronic use of NSAIDS or aspirin 13. Pregnancy or breastfeeding 14. Alcohol consumption greater than 2 glasses/day 15. Hypothyroidism 16. Fish or shellfish allergy

Additional Information

Official title Dietary Omega-3 Fatty Acids as a Therapeutic Strategy in Insulin Resistant Humans
Principal investigator Ian Lanza, PhD
Description Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. No existing studies have systematically evaluated the influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.