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

NCT04947176 | Unknown

• 1 other identifier: 201339
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Baseline to 12 weeks

• Change in Weight

  Baseline to 12 weeks

• Change in BMI

  Baseline to 12 weeks

• Change in serum alanine aminotransferase

  Baseline to 12 weeks

• Change in serum aspartate aminotransferase

  Baseline to 12 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

200mg of pentadecanoic acid (C15:0) supplementation in capsules form

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

Matching placebo in capsules form

Other: Placebo

Interventions

Supplement DIETARY_SUPPLEMENT

200mg C15:0 once daily

Active

Placebo OTHER

Matching placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 through 25 years
• Body Mass Index ≥ 25 Kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeffrey B. Schwimmer, MD: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Robinson MK, Lee E, Ugalde-Nicalo PA, Skonieczny JW, Chun LF, Newton KP, Schwimmer JB. Pentadecanoic Acid Supplementation in Young Adults with Overweight and Obesity: A Randomized Controlled Trial. J Nutr. 2024 Sep;154(9):2763-2771. doi: 10.1016/j.tjnut.2024.07.030. Epub 2024 Jul 26.

  PMID: 39069269 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jeffrey Schwimmer, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 1, 2021
• Study Start: July 6, 2021
• Primary Completion: April 30, 2023
• Study Completion: December 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (1)