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Trial record 1 of 1 for:    NCT04947176 | Recruiting, Not yet recruiting Studies
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C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT04947176
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Schwimmer, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE June 9, 2021
First Posted Date  ICMJE July 1, 2021
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE July 6, 2021
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
Change in plasma C15:0 levels [ Time Frame: Baseline to 12 weeks ]
To determine changes in plasma C15:0 levels in response to daily supplementation of C15:
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline to 12 weeks ]
    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
  • Change in Weight [ Time Frame: Baseline to 12 weeks ]
    Change in Weight (kg)
  • Change in BMI [ Time Frame: Baseline to 12 weeks ]
    Change in BMI (kg/m^2)
  • Change in serum alanine aminotransferase [ Time Frame: Baseline to 12 weeks ]
    Change in serum alanine aminotransferase (U/L)
  • Change in serum aspartate aminotransferase [ Time Frame: Baseline to 12 weeks ]
    Change in serum aspartate aminotransferase (U/L)
  • Change in serum glutamyl transpeptidase [ Time Frame: Baseline to 12 weeks ]
    Change in serum glutamyl transpeptidase (U/L)
  • Change in serum total cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum total cholesterol (mg/dL)
  • Change in serum LDL-cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum LDL-cholesterol (mg/dL)
  • Change in serum HDL-cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum HDL-cholesterol (mg/dL)
  • Change in High Sensitivity C-reactive protein [ Time Frame: Baseline to 12 weeks ]
    Change in High Sensitivity C-reactive protein (mg/L)
  • Change in serum glucose [ Time Frame: Baseline to 12 weeks ]
    Change in serum glucose (mg/dL)
  • Change in serum insulin [ Time Frame: Baseline to 12 weeks ]
    Change in serum insulin (μIU/mL)
  • Change in hemoglobin [ Time Frame: Baseline to 12 weeks ]
    Change in hemoglobin (mg/dL)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome
Official Title  ICMJE A Double Blind, Randomized, Single Center, Controlled, Two Arm Trial of Dietary C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Supplement
    200mg C15:0 once daily
  • Other: Placebo
    Matching placebo once daily
Study Arms  ICMJE
  • Active Comparator: Active
    200mg of pentadecanoic acid (C15:0) supplementation in capsules form
    Intervention: Dietary Supplement: Supplement
  • Placebo Comparator: Placebo
    Matching placebo in capsules form
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia Ugalde-Nicalo, MD 619-543-7673 pugaldenicalo@health.ucsd.edu
Contact: Carissa Carrier, BS 619-543-2442 ccarrier@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04947176
Other Study ID Numbers  ICMJE 201339
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey B. Schwimmer, MD, University of California, San Diego
Study Sponsor  ICMJE Jeffrey B. Schwimmer, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Schwimmer, MD UC San Diego
PRS Account University of California, San Diego
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP