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NCT05560971 · ClinicalTrials.gov registry record · NA
Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes
A NA study of Obesity and Overweight, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05560971: Active NA study of Obesity and Overweight, sponsored by Brigham and Women's Hospital.
NCT05560971 is a NA study of Obesity and Overweight that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 40 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05560971, a NA study of Obesity and Overweight, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 end
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Palmitoleic acid
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What the registry record for NCT05560971 still lists
NCT05560971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05560971 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05560971 about?
NCT05560971 is a clinical study titled "Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes". 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 tha...
What is the current status of trial NCT05560971?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2022-11-01. Estimated completion is 2027-12-31.
What conditions does trial NCT05560971 study?
This clinical trial studies the following conditions: Obesity, Overweight, PreDiabetes, Insulin Resistance.
What interventions are being tested in trial NCT05560971?
The interventions under investigation include: Placebo (OTHER), Palmitoleic acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05560971?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05560971 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05560971's enrollment target sits among peer trials
40 778th of 1053 higher than 249 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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