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Monounsaturated Fatty Acid

Monounsaturated Fatty Acid Supplementation for Prediabetes

N/A
Recruiting
Led By Mehmet Furkan Burak, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial tests if a dietary supplement, Palmitoleic acid (POA), can improve insulin sensitivity & decrease liver fat in overweight/obese adults w/ pre-diabetes. POA acts as a hormone & has been linked to reduced risk of diabetes & heart attacks.

Who is the study for?
Adults aged 18-70 with a BMI of 25-40, prediabetes (HbA1c between 5.6 - 6.5), and no major chronic diseases can join this trial. They should not be pregnant, breastfeeding, or have recently lost significant weight. Participants must not be on certain medications or have had more than three servings/day of high-fat dairy for the last three months.Check my eligibility
What is being tested?
The study is testing if Palmitoleic acid (POA), an omega-7 fat found in diet, can improve insulin sensitivity and reduce liver fat in overweight individuals with prediabetes. This double-blind placebo-controlled trial compares POA against a placebo to see which is more effective.See study design
What are the potential side effects?
While specific side effects are not listed for POA supplementation, potential risks may include digestive discomfort or changes in blood lipid levels due to its impact on metabolism and liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin sensitivity M value change before and 8 weeks after POA vs placebo intake
Secondary outcome measures
Liver fat quantification
Glucose tolerance test
Serum; fasting glucose, insulin, LDL cholesterol, hsCRP, circulating inflammatory cytokines (TNF-a, IL-6), FABP4, glucagon
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Palmitoleic acidActive Control1 Intervention
The treatment arm will receive Palmitoleic acid (POA) supplement as Provinal® 420 mg capsules with at least 90% pure POA Ethyl Ester (less than 1% palmitic acid). Participants will be asked to consume 2 Provinal® 420 mg capsules twice a day for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
The placebo is a medium chain fatty acid in triglyceride form. The placebo has no shown health effects, neither beneficial or detrimental. Participants will be asked to consume 2 placebo capsules daily twice a day for 8 weeks.

Find a Location

Who is running the clinical trial?

Tersus Life Sciences LLCIndustry Sponsor
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,790 Total Patients Enrolled
10 Trials studying Insulin Resistance
810 Patients Enrolled for Insulin Resistance
Mehmet Furkan Burak, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Palmitoleic acid (Monounsaturated Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05560971 — N/A
Insulin Resistance Research Study Groups: Placebo, Palmitoleic acid
Insulin Resistance Clinical Trial 2023: Palmitoleic acid Highlights & Side Effects. Trial Name: NCT05560971 — N/A
Palmitoleic acid (Monounsaturated Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560971 — N/A
Insulin Resistance Patient Testimony for trial: Trial Name: NCT05560971 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to take part in this experiment?

"This clinical trial is recruiting 40 individuals with insulin resistance who are aged 18 to 70. To qualify, they must meet the following criteria: overweight or obese status with prediabetes/impaired glucose tolerance; normal thyroid function as indicated by screening TSH levels; BMI between 25-40 kg/m2; HbA1c between 5.6 - 6.5; impaired fasting plasma glucose (>99, ≤126 mg/dL) or OGTT blood glucose at 2 hours of 140-200 mg/dL; BP <150/90 (with or without medication); GFR>60 and ALT & AST tests <"

Answered by AI

Are medical professionals still looking for volunteers to join the experiment?

"According to clinicaltrials.gov, this scientific experiment is still recruiting participants and was first uploaded on the 1st of November 2022 with its details last modified on that same date."

Answered by AI

Does the eligibility for this experiment extend to geriatric patients?

"This research requires that participants are between 18 and 70 years old, in accordance with the pre-established eligibility criteria."

Answered by AI

How many participants are being recruited for this medical experiment?

"Affirmative. According to the clinicaltrials.gov records, this trial is looking for participants at present - it was first advertised on November 1st 2022 and has been given a refresher recently. 40 patients are necessary from one medical site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am biarei r.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes
Mehmet F. Burak, MD 2022. "Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05560971.
All > Prediabetes > Overweight
~22 spots leftby Dec 2025
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