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

Launched by JEFFREY B. SCHWIMMER, MD · Jun 23, 2021

Keywords

ClinConnect Summary

This clinical trial, called C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome, is looking to understand how taking a daily capsule of C15:0 (a type of fatty acid) for 12 weeks affects young adults who might be at risk for metabolic syndrome. Metabolic syndrome is a group of conditions that can increase the risk of heart disease and diabetes. The study will measure changes in the levels of C15:0 in the blood of participants who are between the ages of 18 and 25 and have a body mass index (BMI) of 25 or higher, which indicates they may be overweight.

To participate, individuals must not have certain health issues, such as diabetes or liver disease, and they should not be taking specific medications that might interfere with the study. Participants will be asked to take the C15:0 supplement daily and attend follow-up appointments to monitor their health during the trial. This study is currently active but not recruiting new participants, so it is primarily assessing the effects of the supplement in those already enrolled.

Gender

ALL

Eligibility criteria

• 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