NCT05560971Active, not recruiting
Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes
The Effect of Palmitoleic Acid (POA) Supplementation on Insulin Sensitivity and Lipogenesis in Overweight and Obese Individuals
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Sept 2022
- Start date
- Jan 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity
- NCT number
- NCT05560971
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Jan 2023 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any medications (except thyroid hormone with normal TSH, anti-hypertensives with blood pressure \<150/90 and non-steroidal rescue inhalers for asthma)
- Greater than 3 servings/day combined of cheese, whole-fat milk, kefir, or whole-fat yogurt for the last 3 months before the study.
- Treatment with any investigational drug in the one month preceding the study
Other illness
- History of ongoing smoking cigarettes \>1 pack/day, alcohol abuse, or illicit drug abuse
Lab values
- Diagnosed with any type of diabetes mellitus and/or taking glucose-lowering medications
- 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)
Other
- 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
- Recent weight loss (more than 7% of total body weight loss in last 3 months)
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.