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Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

Primary Purpose

PreDiabetes, Insulin Resistance, Overweight

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Palmitoleic acid

Placebo

About this trial

This is an interventional other trial for PreDiabetes focused on measuring Palmitoleic acid, Obesity, Insulin resistance, Dietary supplement, Prediabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Overweight and obese individuals with prediabetes and/or impaired glucose tolerance
Age 18 to 70 years
BMI 25-40 kg/m2
HbA1c between 5.6 - 6.5, Impaired fasting plasma glucose levels (>99, ≤126 mg/dL) or OGTT blood glucose at 2 hours between 140-200 mg/dL
BP <150/90 with or without medication
GFR>60
ALT, AST <300
Normal thyroid function is defined as screening TSH within normal ranges, with or without medication

Exclusion Criteria:

Use of any medications (except thyroid hormone with normal TSH, anti-hypertensives with blood pressure <150/90 and non-steroidal rescue inhalers for asthma)
Pregnancy or breastfeeding
Use of over-the-counter (OTC) supplements (except vitamin D). The investigators will ensure that study participants are not using supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation
Greater than 3 servings/day combined of cheese, whole-fat milk, kefir, or whole-fat yogurt for the last 3 months before the study.
Diagnosed with any type of diabetes mellitus and/or taking glucose-lowering medications
Recent weight loss (more than 7% of total body weight loss in last 3 months)
Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, Atrial fibrillation, symptomatic peripheral arterial disease), bleeding disorder or anticoagulation use, active cancer, end-stage renal disease, proteinuria (>3g/day), dementia, severe chronic obstructive pulmonary disease (needs systemic steroid therapy), significant liver disease (ALT or AST>300)
History of ongoing smoking cigarettes >1 pack/day, alcohol abuse, or illicit drug abuse
Treatment with any investigational drug in the one month preceding the study

Sites / Locations

Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Palmitoleic acid

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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 endpoint to see at least 20% difference.

Secondary Outcome Measures

Modified mixed meal tolerance test

The investigators will measure glucose and c-peptide response to standard mixed meal. Study participants will ingest the mixed meal and then the investigators will measure glucose and c-peptide levels from venous blood collected every 30 minutes for 2 hours. Area under the curve (AUC) for both glucose and c-peptide will be calculated and this value from same individuals before and 8 weeks after POA vs placebo intake will be compared.

Liver fat quantification

Liver fat percent will be evaluated by liver MRI-PDFF (proton density fat fraction). Blinded radiologist will analyze the MRI fat fraction and use standard ROI gating. The investigators will compare % fat fraction (FF) from same individuals before and 8 weeks after POA vs placebo intake

Total body fat mass and body composition

Body composition, which is whole-body fat vs lean mass will be evaluated by DEXA scan. Whole-body % fat mass from same individuals before and 8 weeks after POA vs placebo intake will be compared.

Serum; fasting glucose, insulin, LDL cholesterol, hsCRP, circulating inflammatory cytokines (TNF-a, IL-6), FABP4, glucagon

The investigoators will compare serum fasting glucose, insulin, LDL cholesterol, hsCRP, circulating inflammatory cytokines (TNF-a, IL-6), FABP4, glucagon from same individuals before and 8 weeks after POA vs placebo intake

Full Information

NCT ID

NCT05560971

First Posted

September 27, 2022

Last Updated

November 1, 2022

Sponsor

Brigham and Women's Hospital

Collaborators

Tersus Life Sciences LLC

1. Study Identification

Unique Protocol Identification Number

NCT05560971

Brief Title

Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Tersus Life Sciences LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

Specific aims of the study are as follows: 1) To test whether supplementation of POA, as compared to placebo, improves insulin sensitivity. 2) To test whether supplementation of POA, as compared to placebo, ameliorates hepatosteatosis and decreases whole-body fat mass, serum triglyceride, and LDL cholesterol. 3)To determine whether supplementation of POA, as compared to placebo, decreases plasma levels of fasting glucose, insulin, FABP4, glucagon, inflammatory cytokines, and hsCRP. The investigators will recruit overweight and obese individuals (BMI 25-40) with mild insulin resistance, prediabetes and/or impaired glucose tolerance. The study is powered only for the primary endpoint, insulin sensitivity. After the screening visit confirms the eligibility for the study; the investigators will perform an oral glucose tolerance test (OGTT) for stratified randomization for better homogeneity between POA and placebo groups. The investigators aim to have 40 participants complete the study which will consist of 2 main overnight visits consisting of an insulin clamp procedure and a mixed meal tolerance test the night prior. Participants will also have a liver MRI and DEXA scan at these two visits. Participants will be asked to consume a palmitoleic acid minimized diet for 10 weeks which will start two weeks before the first overnight visit. This research study will compare insulin sensitivity before and 8 weeks after taking POA vs placebo in the same individuals. After the first overnight visit participants will be given either POA or placebo capsules to take daily for 8 weeks until the second overnight visit. There will also be a short blood draw visit 4 weeks after the first overnight visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes, Insulin Resistance, Overweight, Obesity

Keywords

Palmitoleic acid, Obesity, Insulin resistance, Dietary supplement, Prediabetes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Interventional double-blinded study with participants randomized to either POA or placebo

Masking

ParticipantInvestigator

Masking Description

Participants and study staff both blinded.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Palmitoleic acid

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Palmitoleic acid

Other Intervention Name(s)

Provinal®

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Modified mixed meal tolerance test

Description

Time Frame

8 weeks

Title

Liver fat quantification

Description

Time Frame

8 weeks

Title

Total body fat mass and body composition

Description

Body composition, which is whole-body fat vs lean mass will be evaluated by DEXA scan. Whole-body % fat mass from same individuals before and 8 weeks after POA vs placebo intake will be compared.

Time Frame

8 weeks

Title

Serum; fasting glucose, insulin, LDL cholesterol, hsCRP, circulating inflammatory cytokines (TNF-a, IL-6), FABP4, glucagon

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Overweight and obese individuals with prediabetes and/or impaired glucose tolerance Age 18 to 70 years BMI 25-40 kg/m2 HbA1c between 5.6 - 6.5, Impaired fasting plasma glucose levels (>99, ≤126 mg/dL) or OGTT blood glucose at 2 hours between 140-200 mg/dL BP <150/90 with or without medication GFR>60 ALT, AST <300 Normal thyroid function is defined as screening TSH within normal ranges, with or without medication Exclusion Criteria: Use of any medications (except thyroid hormone with normal TSH, anti-hypertensives with blood pressure <150/90 and non-steroidal rescue inhalers for asthma) Pregnancy or breastfeeding Use of over-the-counter (OTC) supplements (except vitamin D). The investigators will ensure that study participants are not using supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation Greater than 3 servings/day combined of cheese, whole-fat milk, kefir, or whole-fat yogurt for the last 3 months before the study. Diagnosed with any type of diabetes mellitus and/or taking glucose-lowering medications Recent weight loss (more than 7% of total body weight loss in last 3 months) Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, Atrial fibrillation, symptomatic peripheral arterial disease), bleeding disorder or anticoagulation use, active cancer, end-stage renal disease, proteinuria (>3g/day), dementia, severe chronic obstructive pulmonary disease (needs systemic steroid therapy), significant liver disease (ALT or AST>300) History of ongoing smoking cigarettes >1 pack/day, alcohol abuse, or illicit drug abuse Treatment with any investigational drug in the one month preceding the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lindsey Porter

Phone

781-879-0796

lmporter@bwh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mehmet Furkan Burak, MD

Phone

617-732-5666

mfburak@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Furkan Burak, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsey M Porter

lmporter@bwh.harvard.edu

Ext

Burak

mfburak@partners.org

First Name & Middle Initial & Last Name & Degree

Mehmet F Burak, MD

12. IPD Sharing Statement

Plan to Share IPD

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Monounsaturated Fatty Acid Supplementation for Overweight and Obese Individuals With Prediabetes

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