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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

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Supplement Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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:


Secondary Outcome Measures :
  1. 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

  2. Change in Weight [ Time Frame: Baseline to 12 weeks ]
    Change in Weight (kg)

  3. Change in BMI [ Time Frame: Baseline to 12 weeks ]
    Change in BMI (kg/m^2)

  4. Change in serum alanine aminotransferase [ Time Frame: Baseline to 12 weeks ]
    Change in serum alanine aminotransferase (U/L)

  5. Change in serum aspartate aminotransferase [ Time Frame: Baseline to 12 weeks ]
    Change in serum aspartate aminotransferase (U/L)

  6. Change in serum glutamyl transpeptidase [ Time Frame: Baseline to 12 weeks ]
    Change in serum glutamyl transpeptidase (U/L)

  7. Change in serum total cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum total cholesterol (mg/dL)

  8. Change in serum LDL-cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum LDL-cholesterol (mg/dL)

  9. Change in serum HDL-cholesterol [ Time Frame: Baseline to 12 weeks ]
    Change in serum HDL-cholesterol (mg/dL)

  10. Change in High Sensitivity C-reactive protein [ Time Frame: Baseline to 12 weeks ]
    Change in High Sensitivity C-reactive protein (mg/L)

  11. Change in serum glucose [ Time Frame: Baseline to 12 weeks ]
    Change in serum glucose (mg/dL)

  12. Change in serum insulin [ Time Frame: Baseline to 12 weeks ]
    Change in serum insulin (μIU/mL)

  13. Change in hemoglobin [ Time Frame: Baseline to 12 weeks ]
    Change in hemoglobin (mg/dL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947176


Contacts
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Contact: Patricia Ugalde-Nicalo, MD 619-543-7673 pugaldenicalo@health.ucsd.edu
Contact: Carissa Carrier, BS 619-543-2442 ccarrier@health.ucsd.edu

Locations
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United States, California
UC San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Carissa Carrier    619-543-2442    ccarrier@health.ucsd.edu   
Contact: Patricia Ugalde Nicalo    619-543-7673    pugaldenicalo@health.ucsd.edu   
Sponsors and Collaborators
Jeffrey B. Schwimmer, MD
Investigators
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Principal Investigator: Jeffrey Schwimmer, MD UC San Diego
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Responsible Party: Jeffrey B. Schwimmer, MD, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04947176    
Other Study ID Numbers: 201339
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases