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New treatment option for Overweight
Official title Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate
ClinicalTrials.gov ID: NCT06044935
What this study is testing
- What it's testing
- Background: At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Meet one of the following:
- Adult males aged 18-65 years
- Pre-menopausal adult females aged 18-50 years
- Adult males aged 18-65 years with diagnosed maturity-onset diabetes of the young type 2 (MODY2) or pre-menopausal adult females aged 18-50 years with...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Taking prescription medications or other drugs or supplements that may influence energy metabolism or nutrient digestion or absorption (including...
- Indicators of liver disease; combination of both albumin \ 3 mg/mL
- Individuals with significant medical comorbidities (e.g., non-MODY2 diabetes, NYHA Class \>II heart failure, or CKD Stage II or worse, or American...
- Individuals taking prescription medications to treat hypertension in participants without MODY2
- Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Meet one of the following:
- Adult males aged 18-65 years
- Pre-menopausal adult females aged 18-50 years
- Adult males aged 18-65 years with diagnosed maturity-onset diabetes of the young type 2 (MODY2) or pre-menopausal adult females aged 18-50 years with diagnosed MODY2
- Weight stable (\< +/- 5 % body weight change over past 6 months) as determined by volunteer report
- Body mass index (BMI) \>= 25 kg/m\^2 (of \>=18.5 kg/m\^2 for patients with MODY2)
- Able to cycle at a moderate rate and intensity with a HR equal to or greater than 0.3x(220-age-HRrest)+HRrest but not exceeding 0.4x(220-age-HRrest)+HRrest with no signs of arrhythmia
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Taking prescription medications or other drugs or supplements that may influence energy metabolism or nutrient digestion or absorption (including, but not limited to, diet/weight-loss medication or other medications at...
- Indicators of liver disease; combination of both albumin \ 3 mg/mL
- Individuals with significant medical comorbidities (e.g., non-MODY2 diabetes, NYHA Class \>II heart failure, or CKD Stage II or worse, or American Society of Anesthesiologists Physical Status Class 3 or above)
- Individuals taking prescription medications to treat hypertension in participants without MODY2
- Participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report
- Positive pregnancy test (only for people who can get pregnant)
- Hematocrit \< 40% (men only)
- Hematocrit \<37% (women only)
- Caffeine consumption \> 300 mg/day as determined by volunteer report
- Alcohol consumption \> 3 drinks per day for men or \> 2 drinks per day for women as determined by volunteer report
- Regular use of tobacco (smoking or chewing), e-cigarettes (a.k.a. vapes), nicotine patches, or illicit drugs over past 6 months as determined by volunteer report. people may also be excluded based on a urine drug test.
- Psychological conditions as determined by volunteer report such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study...
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
- Unwilling or unable to comply with or perform all study procedures (e.g. cycling or activities of daily living), or unavailability for the duration of the study, as determined by participant or investigator discretion
- Unwilling or unable to adhere to Lifestyle Considerations throughout study duration, as determined by participant or investigator discretion
- Volunteers unwilling or unable to give informed consent
- Participants with a measured Resting Energy Expenditure (REE) more than 30% above or below the predicted REE based on Mifflin St Jeor equation
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.