Metabolic SyndromeNCT04947176
C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome
A study testing Supplement in people with Metabolic Syndrome, run by Jeffrey B. Schwimmer, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 through 25 years
- Body Mass Index ≥ 25 Kg/m2
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Supplement, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
200mg C15:0 once daily
PlaceboOther
Matching placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 200mg of pentadecanoic acid (C15:0) supplementation in capsules form Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | Matching placebo in capsules form Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma C15:0 levels
To determine changes in plasma C15:0 levels in response to daily supplementation of C15:
Measured: Baseline to 12 weeks
Secondary outcomes (13)
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
Measured: Baseline to 12 weeks
Change in Weight
Change in Weight (kg)
Measured: Baseline to 12 weeks
Change in BMI
Change in BMI (kg/m^2)
Measured: Baseline to 12 weeks
Change in serum alanine aminotransferase
Change in serum alanine aminotransferase (U/L)
Measured: Baseline to 12 weeks
Change in serum aspartate aminotransferase
Change in serum aspartate aminotransferase (U/L)
Measured: Baseline to 12 weeks
Change in serum glutamyl transpeptidase
Change in serum glutamyl transpeptidase (U/L)
Measured: Baseline to 12 weeks
Change in serum total cholesterol
Change in serum total cholesterol (mg/dL)
Measured: Baseline to 12 weeks
Change in serum LDL-cholesterol
Change in serum LDL-cholesterol (mg/dL)
Measured: Baseline to 12 weeks
Change in serum HDL-cholesterol
Change in serum HDL-cholesterol (mg/dL)
Measured: Baseline to 12 weeks
Change in High Sensitivity C-reactive protein
Change in High Sensitivity C-reactive protein (mg/L)
Measured: Baseline to 12 weeks
Change in serum glucose
Change in serum glucose (mg/dL)
Measured: Baseline to 12 weeks
Change in serum insulin
Change in serum insulin (μIU/mL)
Measured: Baseline to 12 weeks
Change in hemoglobin
Change in hemoglobin (mg/dL)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start6 Jul 2021
- Primary completion30 Apr 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey B. Schwimmer, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey B. Schwimmer, MD, University of California, San Diego
- Investigators
- Jeffrey Schwimmer, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947176
- Sponsor's protocol ID
- 201339
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39069269
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04947176
- Acronym / sponsor ID
- 201339
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jeffrey B. Schwimmer, MDUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Supplement200mg of pentadecanoic acid (C15:0) supplementation in capsules form |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo in capsules form |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 through 25 years
- Body Mass Index ≥ 25 Kg/m2
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement200mg C15:0 once daily | Dietary supplement | Active |
| PlaceboMatching placebo once daily | Other | Placebo |
Primary outcome
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:
13 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Baseline to 12 weeks
Change in Weight
Time frame: Baseline to 12 weeks
Change in BMI
Time frame: Baseline to 12 weeks
Change in serum alanine aminotransferase
Time frame: Baseline to 12 weeks
Change in serum aspartate aminotransferase
Time frame: Baseline to 12 weeks
Change in serum glutamyl transpeptidase
Time frame: Baseline to 12 weeks
Change in serum total cholesterol
Time frame: Baseline to 12 weeks
Change in serum LDL-cholesterol
Time frame: Baseline to 12 weeks
Change in serum HDL-cholesterol
Time frame: Baseline to 12 weeks
Change in High Sensitivity C-reactive protein
Time frame: Baseline to 12 weeks
Change in serum glucose
Time frame: Baseline to 12 weeks
Change in serum insulin
Time frame: Baseline to 12 weeks
Change in hemoglobin
Time frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 39069269Robinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Schwimmer, MD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Metabolic Syndrome, run by Jeffrey B. Schwimmer, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma C15:0 levels (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04947176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.