Clinical trial

Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05560971

Active, not recruitingNot applicableInterventional

What this study is about

The purpose of this study is to understand and determine whether Palmitoleic acid (POA), monounsaturated omega-7 fatty acid (exists in regular diet), improves insulin sensitivity and decreases liver fat accumulation in humans. Unlike others, the study will use POA as a dietary supplement, rather than complex oils, which contain a significant amount of saturated fat palmitic acid. Palmitic acid has known harmful effects on the body. Hence, eliminating palmitic acid from supplementation of POA might increase its benefits. This trial stems from the preclinical discoveries that POA acting as a fat hormone, has beneficial effects on the liver, muscle, vessels, and fat tissue. Supporting this, higher POA levels in humans have been shown to be correlated with a reduced risk of developing type-2 diabetes and cardiovascular diseases such as heart attacks. In animals, it has been observed that POA improves sugar metabolism in a number of mechanisms related to the liver and muscle. Based on these findings, the design of this study is a double-blind placebo-controlled trial that tests the effects of POA on insulin sensitivity of overweight and obese adult individuals with pre-diabetes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionPreDiabetes, Insulin Resistance, Overweight, Obesity

Full registry criteria

Inclusion Criteria: * Overweight and obese individuals with prediabetes and/or impaired glucose tolerance * Age 18 to 70 years * BMI 25-40 kg/m2 * HbA1c between 5.6 - 6.5, Impaired fasting plasma glucose levels (\>99, ≤126 mg/dL) or OGTT blood glucose at 2 hours between 140-200 mg/dL or HOMA-IR \>2.5 * BP \<150/90 with or without medication * GFR\>60 * ALT, AST \<300 * Normal thyroid function is defined as screening TSH within normal ranges, with or without medication Exclusion Criteria: * Use of any medications (except thyroid hormone with normal TSH, anti-hypertensives with blood pressure \<150/90 and non-steroidal rescue inhalers for asthma) * Pregnancy or breastfeeding * Use of over-the-counter (OTC) supplements (except vitamin D). The investigators will ensure that study participants are not using supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation * Greater than 3 servings/day combined of cheese, whole-fat milk, kefir, or whole-fat yogurt for the last 3 months before the study. * Diagnosed with any type of diabetes mellitus and/or taking glucose-lowering medications * Recent weight loss (more than 7% of total body weight loss in last 3 months) * Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, Atrial fibrillation, symptomatic peripheral arterial disease), bleeding disorder or anticoagulation use, active cancer, end-stage renal disease, proteinuria (\>3g/day), dementia, severe chronic obstructive pulmonary disease (needs systemic steroid therapy), significant liver disease (ALT or AST\>300) * History of ongoing smoking cigarettes \>1 pack/day, alcohol abuse, or illicit drug abuse * Treatment with any investigational drug in the one month preceding the study

Treatments and study arms

Palmitoleic acid

Dietary Supplement

Participants will be randomized to either POA or placebo and will be asked to take 2 capsules of the POA or placebo twice a day for 8 weeks.

Placebo

Other

Medium chain fatty acids in triglyceride form in capsules with the same shape, color, size and odor of POA capsules

Primary outcomes

Insulin sensitivity M value change before and 8 weeks after POA vs placebo intake8 weeks

Insulin sensitivity (M values) will be evaluated by hyperinsulinemic euglycemic clamp (gold standard) from the same individuals before and after taking POA vs. placebo. The investigators will compare M values before and after taking POA vs placebo intake. Hence the investigators are looking for delta changes and expect 20% statistically significant improvement with POA and no significant change with placebo. The investigators calculated sample size and powered the study for only this primary endpoint to see at least 20% difference.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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