C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome

Jeffrey B. Schwimmer, MD

Status

Active, not recruiting

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Supplement

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04947176

201339

Details and patient eligibility

About

This study will determine changes in plasma C15:0 levels in young adults with BMI ≥ 25 in response to 12 weeks of daily oral C15:0 supplementation.

Full description

Metabolic syndrome is a disturbance in how the body processes both carbohydrates and fats. This condition has become common in children and young adults, especially in association with excess body fat. People with metabolic syndrome are at increased risk for type 2 diabetes, cardiovascular disease, and nonalcoholic fatty liver disease (NAFLD). Diet is believed to play an important role in both developing and treating metabolic syndrome. Studies have shown that low dietary intake of a type of fats known as odd chain fatty acids is associated with a higher risk for each of the metabolic syndrome associated conditions of diabetes, heart disease, and liver disease. Supplementation with one specific odd chain fatty acid known as C15:0 has shown to decrease the effects of metabolic syndrome in both cellular and animal models. In people, the epidemiology of consumption of C15:0 in the diet is consistent with this belief. However, clinical trials have yet to be done with supplemental C15:0. This study is a pilot study of C15:0 supplementation in a group of young adults at risk for metabolic syndrome. The study will determine how well supplementation with C15:0 daily for 12 weeks is able to raise levels of C15:0 in the blood when compared to placebo. The study will also look for signs that increasing blood levels of C15:0 leads to changes in physiology.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 through 25 years
Body Mass Index ≥ 25 Kg/m2

Exclusion criteria

Reported habitual dietary intake of C15:0 that consistently exceeds 250 mg per day
Significant alcohol consumption (average consumption >1 drink/day for females, >2 drink/day for males or episodes of binge drinking >5 drinks/day)
Inability to swallow capsules
Type 1 or Type 2 Diabetes
Liver Cirrhosis
Pregnancy
Body weight greater than 125 kg at screening
LDL-cholesterol > 160 mg/dL
Triglycerides > 500 mg/dL
Hemoglobin < 10.0 gm/dL
Current Omega 3 Fatty Acid supplement usage
Current use of Statin medications
Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
Patients who are currently enrolled in a clinical trial or who received an investigational study drug within 180 days of screening.
Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator.
Failure to give informed consent