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

A Double Blind, Randomized, Single Center, Controlled, Two Arm Trial of Dietary C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Supplement; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 200mg of pentadecanoic acid (C15:0) supplementation in capsules form	Dietary supplement: Supplement; 200mg C15:0 once daily
Placebo Comparator: Placebo; Matching placebo in capsules form	Other: Placebo; Matching placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma C15:0 levels	To determine changes in plasma C15:0 levels in response to daily supplementation of C15:	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	To assess safety and tolerability of C15:0 supplementation as measured by number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Baseline to 12 weeks
Change in Weight	Change in Weight (kg)	Baseline to 12 weeks
Change in BMI	Change in BMI (kg/m^2)	Baseline to 12 weeks
Change in serum alanine aminotransferase	Change in serum alanine aminotransferase (U/L)	Baseline to 12 weeks
Change in serum aspartate aminotransferase	Change in serum aspartate aminotransferase (U/L)	Baseline to 12 weeks
Change in serum glutamyl transpeptidase	Change in serum glutamyl transpeptidase (U/L)	Baseline to 12 weeks
Change in serum total cholesterol	Change in serum total cholesterol (mg/dL)	Baseline to 12 weeks
Change in serum LDL-cholesterol	Change in serum LDL-cholesterol (mg/dL)	Baseline to 12 weeks
Change in serum HDL-cholesterol	Change in serum HDL-cholesterol (mg/dL)	Baseline to 12 weeks
Change in High Sensitivity C-reactive protein	Change in High Sensitivity C-reactive protein (mg/L)	Baseline to 12 weeks
Change in serum glucose	Change in serum glucose (mg/dL)	Baseline to 12 weeks
Change in serum insulin	Change in serum insulin (μIU/mL)	Baseline to 12 weeks
Change in hemoglobin	Change in hemoglobin (mg/dL)	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Jeffrey B. Schwimmer, MD
• Investigators: Principal Investigator: Jeffrey Schwimmer, MD, UC San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 201339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No