A Study of Niacin Regulation for Excessive Weight Gain

This study is looking at how Niacin, given through an IV (intravenous, meaning directly into a vein), affects people who have excessive weight gain, especially around their stomach. Researchers want to understand why fat cells in people with different body types respond differently. You could join if you are between 18 and 65 years old, have a BMI (Body Mass Index) between 29.0 and 40.0 kg/m2, and can follow study instructions. The main goal is to see how Niacin changes the levels of free fatty acids in your blood about 4 hours after treatment. The current status of this study is unclear, and it plans to enroll 32 participants.

Study design: This interventional study plans to enroll 32 participants. It involves a single administration of Niacin.
What's involved: You would receive Niacin intravenously for about 4.5 hours on one occasion. You would also need to eat all your meals from the Mayo CRTU for at least 3 days before the study.
Compensation: Not stated in the trial record.
Follow-up: Your plasma free fatty acid levels will be measured at the beginning of the study and approximately 4 hours after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of Niacin Regulation

Recruiting

EARLY_PHASE1Ages 18–65InterventionalBasic science

Mayo Clinic

~32 participants

Updated 2026-04-13 on ClinicalTrials.gov

What's tested:Niacin

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in plasma free fatty acid (FFA) concentrations

Measured over Baseline, post treatment (approximately 4 hours)

Conditions

Excessive Weight Gain

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Michael Jensen, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Pamela Reich

[email protected]

507-255-6062

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study.

Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2.

Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \> 0.95 and/or increased visceral fat (visceral fat area \> 180 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.

Female subjects are eligible if they meet the following criteria: are not pregnant or nursing; all women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods.

Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer: if Yes look at consent form and f/u visits: current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude;

Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks.

Previous labs: HbA1C \< 6.5% for non-diabetic UBO; Fasting glucose \< 126 mg/dl for non-diabetic UBO; Hb ≥ 11.0 for women and ≥ 12 for men; platelets \> 100 000.

Exclusion

Individuals with a history of a disease process such as: ischemic heart disease; atherosclerotic valvular disease; persistent blood pressure greater than 160/95 despite antihypertensive medication.

Smokers.

Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (\>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics.

Allergy to lidocaine.

Allergy to Niaspan documented by immunological testing.

Allergy to indocyanine green.

What this trial measures

Change in plasma free fatty acid (FFA) concentrationsBaseline, post treatment (approximately 4 hours)
Measurement of plasma free fatty acid (FFA) concentrations from femoral, upper body subcutaneous adipose tissue expressed as nmol•million adipocytes-1•min-1

Trialytics