Omega-3 Fatty Acids and Insulin Sensitivity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-21

Study Completion Date

2015-06-08

Brief Summary

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

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Detailed Description

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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.

A sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content of total, pro- (M1) and anti- (M2) inflammatory macrophages (immunohistochemistry), crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining), as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor ((U-13C)palmitate) infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (IC50(palmitate)f).

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3

Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.

Group Type EXPERIMENTAL

Omega-3

Intervention Type DRUG

Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.

Placebo

Patients in this group will be supplemented with placebo capsules containing ethyl oleate.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Omega-3

Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Essential fatty acids Omega-3 fatty acids Omega-3 polyunsaturated fatty acids PUFAs Lovaza

Eligibility Criteria

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Inclusion Criteria

1. Age 18-65 years
2. Insulin resistant (Homeostasis Model Assessment (HOMA) Insulin Resistance (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\>144 IU/L and alanine transaminase (ALT)\>165 IU/L)
9. Anti-coagulant therapy (warfarin/heparin)
10. International normalized ratio (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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes