CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 40 target
Drug / intervention
Palmitoleic acid +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05560971
NCT05560971N/AActiveOn TrackUpdated 16mo ago

The Effect of Palmitoleic Acid (POA) Supplementation on Insulin Sensitivity and Lipogenesis in Overweight and Obese Individuals

Brigham and Women's Hospital·interventional·Posted Sep 30, 2022·Updated Feb 5, 2025

In Brief

A clinical study evaluating Palmitoleic acid and Placebo for PreDiabetes and 3 related conditions. Active but no longer recruiting, targeting 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActive
202320242025202620272028
First PostedSep 30, 2022
Enrollment StartNov 1, 2022
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 3.8 years agoPrimary completion in 6 months

Interventions

Palmitoleic aciddietary

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.

Placeboother

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