What side effects are associated with this type of intervention?

Common treatments for insulin resistance, such as Palmitoleic Acid, alpha-lipoic acid, and thiazolidinediones, generally aim to improve insulin sensitivity and reduce liver fat. Palmitoleic Acid, a monounsaturated fatty acid, is well-tolerated with minimal side effects, though more research is needed. Alpha-lipoic acid can cause gastrointestinal issues like nausea and diarrhea. Thiazolidinediones, such as pioglitazone, may lead to weight gain, edema, and an increased risk of heart failure. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

FDA-approved treatments for insulin resistance include thiazolidinediones such as pioglitazone and rosiglitazone, which improve insulin sensitivity by activating PPAR-gamma receptors. Additionally, GLP-1 receptor agonists like liraglutide and semaglutide, which are used for both diabetes and obesity, have shown efficacy in improving glycemia and reducing liver fat. These treatments share similarities with Palmitoleic Acid in their mechanisms of improving insulin sensitivity and addressing liver fat accumulation.

What other types of research exist?

Promising alternatives to Palmitoleic Acid for insulin resistance include: 1) SGLT2 inhibitors, which improve insulin sensitivity and have shown benefits in patients with diabetes and cirrhosis. 2) Omega-3 polyunsaturated fatty acids, which modulate inflammatory responses and have been associated with reduced risk of autoimmune diseases like type 1 diabetes. 3) Thiazolidinediones, such as pioglitazone, which can increase limb fat and improve insulin resistance, though they come with safety concerns. 4) Tesamorelin, which reduces visceral and hepatic fat and improves lipid profiles by stimulating growth hormone secretion.

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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

Summary

This trial is testing a supplement called Palmitoleic acid on overweight and obese adults with pre-diabetes. The supplement aims to improve how the body handles sugar and reduce liver fat. It works by helping the liver, muscles, and fat tissue function better.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin sensitivity M value change before and 8 weeks after POA vs placebo intake

Secondary study objectives

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insulin resistance, such as Palmitoleic Acid, work by improving insulin sensitivity and reducing liver fat accumulation. Palmitoleic Acid acts as a fat hormone, enhancing glucose metabolism in the liver and muscle tissues, which helps lower blood sugar levels and reduce fat buildup in the liver. This is crucial for insulin resistance patients as it helps prevent the progression to type 2 diabetes and reduces the risk of associated cardiovascular diseases. Other treatments, like thiazolidinediones, also improve insulin sensitivity by activating PPAR-gamma receptors, which regulate fat storage and glucose metabolism. These mechanisms are vital for managing insulin resistance and improving overall metabolic health.