Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
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Record History

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  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2028 Show 8 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Start date: Nov 1, 2022 to Jan 1, 2023
    • Study completion pushed from Dec 31, 2027 to Jun 1, 2029
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
    • Collaborators: 1 to 2
    • Publications: details revised at 36 of 36 entries
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Site details revised
    v4
  3. Site contact updated
    • Eligibility criteria expanded, about 3 words
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Brigham and Women's Hospital
438 trials monitored
See 32 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
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.
Trial Details
NCT Number NCT05560971
Lead Sponsor Brigham and Women's Hospital
Collaborators: Tersus Life Sciences LLC, Istanbul Nisantasi University
Conditions
(from sponsor)		 PreDiabetes, Insulin Resistance, Overweight, Obesity
Related terms Insulin Resistance, Obesity, Overweight, Prediabetic State
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov