Clinical trial NCT04947176: C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome
Official title: A Double Blind, Randomized, Single Center, Controlled, Two Arm Trial of Dietary C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

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

Primary outcomes:
measure: Change in plasma C15:0 levels
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Baseline to 12 weeks
measure: Change in Weight
timeFrame: Baseline to 12 weeks
measure: Change in BMI
timeFrame: Baseline to 12 weeks
measure: Change in serum alanine aminotransferase
timeFrame: Baseline to 12 weeks
measure: Change in serum aspartate aminotransferase
timeFrame: Baseline to 12 weeks
measure: Change in serum glutamyl transpeptidase
timeFrame: Baseline to 12 weeks
measure: Change in serum total cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in serum LDL-cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in serum HDL-cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in High Sensitivity C-reactive protein
timeFrame: Baseline to 12 weeks
measure: Change in serum glucose
timeFrame: Baseline to 12 weeks
measure: Change in serum insulin
timeFrame: Baseline to 12 weeks
measure: Change in hemoglobin
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Jeffrey Schwimmer, MD
role: PRINCIPAL_INVESTIGATOR
References: