OverweightNCT06044935
Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate
A study testing Standard Diet, Ketogenic Diet and Nicotinamide Riboside in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Standard Diet, Ketogenic Diet and Nicotinamide Riboside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 the discretion of the PI and/or study team)
- Indicators of liver disease; combination of both albumin < 2.8 mg/mL and bilirubin > 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
Show all 18Show fewer
- 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. Subjects 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, as determined by investigators
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation &Amp;Amp;Amp;Amp; Metabolic Rate
Background:
At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem.
Read more
Objective:
To test how (1) a low-carbohydrate diet and (2) a supplement called nicotinamide riboside (NR) affect how a person s body uses dietary fat.
Eligibility:
Men aged 18 to 65 and women aged 18 to 50 who are healthy volunteers with a body mass index (height to weight ratio) of 25 or more. Adults with maturity-onset diabetes of the young type 2 (MODY2) are also needed.
Design:
Participants with diabetes will have 1 screening visit and a 9-day clinic stay. Healthy volunteers will have 1 screening visit and 2 clinic stays of 1 to 2 weeks each.
During screening, all participants will have a physical exam with blood and urine tests. They will have their heart rhythm measured while riding a gym bike.
NR is a pill taken by mouth. Only healthy volunteers will take the NR, for 14 days at a time, during 1 clinic stay. During their other stay, they will take placebos; these are pills that look like the study supplement but contain no NR.
During each clinic stay, all participants will eat a normal American diet. Then they will eat a ketogenic "low-carb" diet for 5 days.
Participants will have many tests, including:
Sleeping every night and having two 24-hour stays in a special room that measures the gases their body uses and produces.
Drinking a high-fat shake, then remaining seated for 5 hours while their blood and breath are monitored.
Having a substance injected into the arm and remaining seated for 3 hours while their blood is measured.
Wearing monitors to measure their activity levels. Another monitor will measure their blood glucose levels.
Having imaging scans.
...
Read the detailed description
Study Description:
This is a randomized, double-blind, placebo-controlled crossover study of adults with overweight or obesity to determine whether nicotinamide riboside supplementation increases sleeping energy expenditure and fat oxidation rate during a ketogenic diet.
Objectives:
Primary Aim 1: Determine whether sleeping energy expenditure increases after transitioning to a low carbohydrate ketogenic diet as compared to a baseline high carbohydrate run-in diet in men
Primary Aim 2: Determine whether sleeping energy expenditure is affected by NR supplementation during a ketogenic diet in men
Secondary Aim 1: Determine whether fat oxidation during sleep increases after transitioning to a low carbohydrate ketogenic diet as compared to a baseline high carbohydrate run-in diet in men
Secondary Aim 2: Determine whether fat oxidation during sleep is affected by NR supplementation during a ketogenic diet from the baseline run-in diet in men
Exploratory Aims: Exploratory comparison of the above endpoints between men and women without MODY2.
Exploratory comparison of the above diet-related endpoints between patients with MODY2 and those obtained during the Placebo period in other participants.
Several exploratory measurements are planned to help comprehensively phenotype the effects of the diets and nicotinamide riboside supplementation and are intended to be hypothesis-generating. We will assess the following:
- Liver TG
- Daily ketosis, insulin secretion, and protein utilization
- Rates of ketogenesis and lipolysis
- Physical activity and sleep assessment
- Body composition assessment
- Fasting and postprandial blood measurements of various metabolites, hormones, cytokines, markers of inflammation , and other circulating signaling factors.
- Microbiome composition
- Hunger and satiety before and after meals
- Eating rate
- Chronotype and sleep quality
- Usual food intake
- 24-h and exercise energy expenditure
Endpoints:
Primary:
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet
Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Secondary:
Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet
Exploratory:
- H magnetic resonance spectroscopy
- 24hr urine ketones, C-peptide, nitrogen
- Stable isotope infusions of 13C beta-hydroxybutyrate and 2H glycerol
- Daily accelerometry and wireless EEG headband
- DXA scans
- Fasting and postprandial blood concentrations of various metabolites, hormones, cytokines, inflammatory markers and other circulating signaling factors
- Blood glucose variability and mean concentration as measured by Continuous Glucose Monitoring
- Daily fasting glucose and beta-hydroxybutyrate concentrations by finger-prick
- Microbiome composition
- Hunger and satiety visual analogue scores
- Meal duration
- Pittsburg sleep quality index, morningness-eveningness questionnaire, and subjective sleep visual analogue scores
- Usual food intake as measured by Food frequency questionnaire
- 24-h and exercise energy expenditure from respiratory chamber
- Conditions
- Overweight, Obesity
- Being tested
- Standard Diet, Ketogenic Diet, Placebo, Nicotinamide Riboside
- Keywords
- Ketogenic Diet, Sleep, Energy Expenditure, Supplement, Calories
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DietOther
Consisting of 15% protein, 35% fat, and 50% carbohydrate, matching the macronutrient composition of a typical American diet
Ketogenic DietOther
Consisting of a macronutrient composition of 15% protein, 80% fat, and 5% carbohydrate
PlaceboDietary supplement
Subjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase
Nicotinamide RibosideDietary supplement
Subjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase
| Study group | Role | What they receive |
|---|---|---|
| Men with overweight or obesity | Experimental | To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity Receives: Other: Standard Diet; Other: Ketogenic Diet; Dietary Supplement: Placebo; Dietary Supplement: Nicotinamide Riboside |
| MODY2 Patients | Experimental | To measure changes in sleeping energy expenditure and fat oxidation rate after transitioning from a baseline diet to an isocaloric ketogenic diet similar to our previous study in men Receives: Other: Standard Diet; Other: Ketogenic Diet; Dietary Supplement: Placebo |
| Women with overweight or obesity | Experimental | To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity Receives: Other: Standard Diet; Other: Ketogenic Diet; Dietary Supplement: Placebo; Dietary Supplement: Nicotinamide Riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet
Mean change in sleeping energy expenditure measured by room calorimetry from 2 days of standard run-in diet to 5 days of ketogenic diet
Measured: 7 days
Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Mean difference in sleeping energy expenditure measured by room calorimetry during 5 days of ketogenic diet with NR supplementation or placebo
Measured: 5 days
Secondary outcomes (2)
Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet
Mean change in sleeping fat oxidation measured by room calorimetry from 2 days of standard run-in diet to 5 days of ketogenic diet
Measured: 7 days
Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet
Mean difference in sleeping fat oxidation measured by room calorimetry during 5 days of ketogenic diet with NR supplementation or placebo
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (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 OverweightStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie T Chung, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044935
- Sponsor's protocol ID
- 10001690
- Other IDs
- 001690-DK
- Status last verified
- 16 Sep 2026
- First submitted
- 19 Sep 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographics, anthropometrics, indirect calorimetry data, circulating metabolites and hormones
Publications
Hall KD, Chen KY, Guo J, Lam YY, Leibel RL, Mayer LE, Reitman ML, Rosenbaum M, Smith SR, Walsh BT, Ravussin E. Energy expenditure and body composition changes after an isocaloric ketogenic diet in overweight and obese men. Am J Clin Nutr. 2016 Aug;104(2):324-33. doi: 10.3945/ajcn.116.133561. Epub 2016 Jul 6.
PubMed 27385608
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation &Amp;Amp;Amp;Amp; Metabolic Rate
- ClinicalTrials.gov ID
- NCT06044935
- Acronym / sponsor ID
- 10001690
- Conditions
- Overweight, Obesity
- Keywords
- Ketogenic Diet, Sleep, Energy Expenditure, Supplement, Calories
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 21 Sep 2023 (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.
Background:
At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem.
Objective:
To test how (1) a low-carbohydrate diet and (2) a supplement called nicotinamide riboside (NR) affect how a person s body uses dietary fat.
Eligibility:
Men aged 18 to 65 and women aged 18 to 50 who are healthy volunteers with a body mass index (height to weight ratio) of 25 or more. Adults with maturity-onset diabetes of the young type 2 (MODY2) are also needed.
Design:
Participants with diabetes will have 1 screening visit and a 9-day clinic stay. Healthy volunteers will have 1 screening visit and 2 clinic stays of 1 to 2 weeks each.
During screening, all participants will have a physical exam with blood and urine tests. They will have their heart rhythm measured while riding a gym bike.
NR is a pill taken by mouth. Only healthy volunteers will take the NR, for 14 days at a time, during 1 clinic stay. During their other stay, they will take placebos; these are pills that look like the study supplement but contain no NR.
During each clinic stay, all participants will eat a normal American diet. Then they will eat a ketogenic "low-carb" diet for 5 days.
Participants will have many tests, including:
Sleeping every night and having two 24-hour stays in a special room that measures the gases their body uses and produces.
Drinking a high-fat shake, then remaining seated for 5 hours while their blood and breath are monitored.
Having a substance injected into the arm and remaining seated for 3 hours while their blood is measured.
Wearing monitors to measure their activity levels. Another monitor will measure their blood glucose levels.
Having imaging scans.
...
Detailed description
Study Description:
This is a randomized, double-blind, placebo-controlled crossover study of adults with overweight or obesity to determine whether nicotinamide riboside supplementation increases sleeping energy expenditure and fat oxidation rate during a ketogenic diet.
Objectives:
Primary Aim 1: Determine whether sleeping energy expenditure increases after transitioning to a low carbohydrate ketogenic diet as compared to a baseline high carbohydrate run-in diet in men
Primary Aim 2: Determine whether sleeping energy expenditure is affected by NR supplementation during a ketogenic diet in men
Secondary Aim 1: Determine whether fat oxidation during sleep increases after transitioning to a low carbohydrate ketogenic diet as compared to a baseline high carbohydrate run-in diet in men
Secondary Aim 2: Determine whether fat oxidation during sleep is affected by NR supplementation during a ketogenic diet from the baseline run-in diet in men
Exploratory Aims: Exploratory comparison of the above endpoints between men and women without MODY2.
Exploratory comparison of the above diet-related endpoints between patients with MODY2 and those obtained during the Placebo period in other participants.
Several exploratory measurements are planned to help comprehensively phenotype the effects of the diets and nicotinamide riboside supplementation and are intended to be hypothesis-generating. We will assess the following:
- Liver TG
- Daily ketosis, insulin secretion, and protein utilization
- Rates of ketogenesis and lipolysis
- Physical activity and sleep assessment
- Body composition assessment
- Fasting and postprandial blood measurements of various metabolites, hormones, cytokines, markers of inflammation , and other circulating signaling factors.
- Microbiome composition
- Hunger and satiety before and after meals
- Eating rate
- Chronotype and sleep quality
- Usual food intake
- 24-h and exercise energy expenditure
Endpoints:
Primary:
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet
Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Secondary:
Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet
Exploratory:
- H magnetic resonance spectroscopy
- 24hr urine ketones, C-peptide, nitrogen
- Stable isotope infusions of 13C beta-hydroxybutyrate and 2H glycerol
- Daily accelerometry and wireless EEG headband
- DXA scans
- Fasting and postprandial blood concentrations of various metabolites, hormones, cytokines, inflammatory markers and other circulating signaling factors
- Blood glucose variability and mean concentration as measured by Continuous Glucose Monitoring
- Daily fasting glucose and beta-hydroxybutyrate concentrations by finger-prick
- Microbiome composition
- Hunger and satiety visual analogue scores
- Meal duration
- Pittsburg sleep quality index, morningness-eveningness questionnaire, and subjective sleep visual analogue scores
- Usual food intake as measured by Food frequency questionnaire
- 24-h and exercise energy expenditure from respiratory chamber
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Men with overweight or obesity | Experimental | Other: Standard Diet, Other: Ketogenic Diet, Dietary Supplement: Placebo, Dietary Supplement: Nicotinamide RibosideTo investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity |
| MODY2 Patients | Experimental | Other: Standard Diet, Other: Ketogenic Diet, Dietary Supplement: PlaceboTo measure changes in sleeping energy expenditure and fat oxidation rate after transitioning from a baseline diet to an isocaloric ketogenic diet similar to our previous study in men |
| Women with overweight or obesity | Experimental | Other: Standard Diet, Other: Ketogenic Diet, Dietary Supplement: Placebo, Dietary Supplement: Nicotinamide RibosideTo investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Meet one of the following:
- 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
Key exclusion criteria (18 listed)
- 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 the discretion of the PI and/or study team)
- Indicators of liver disease; combination of both albumin < 2.8 mg/mL and bilirubin > 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
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 |
|---|---|---|
| Standard DietConsisting of 15% protein, 35% fat, and 50% carbohydrate, matching the macronutrient composition of a typical American diet | Other | MODY2 Patients, Men with overweight or obesity, Women with overweight or obesity |
| Ketogenic DietConsisting of a macronutrient composition of 15% protein, 80% fat, and 5% carbohydrate | Other | MODY2 Patients, Men with overweight or obesity, Women with overweight or obesity |
| PlaceboSubjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase | Dietary supplement | MODY2 Patients, Men with overweight or obesity, Women with overweight or obesity |
| Nicotinamide RibosideSubjects without MODY2 will take either placebo or NR (1 g BID, 2 g per day total) supplements for 7 days during this Run-in phase | Dietary supplement | Men with overweight or obesity, Women with overweight or obesity |
Primary outcome
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet
Time frame: 7 days
Mean change in sleeping energy expenditure measured by room calorimetry from 2 days of standard run-in diet to 5 days of ketogenic diet
Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Time frame: 5 days
Mean difference in sleeping energy expenditure measured by room calorimetry during 5 days of ketogenic diet with NR supplementation or placebo
2 secondary outcomes
Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet
Time frame: 7 days
Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 27385608Hall KD, Chen KY, Guo J, Lam YY, Leibel RL, Mayer LE, Reitman ML, Rosenbaum M, Smith SR, Walsh BT, Ravussin E. Energy expenditure and body composition changes after an isocaloric ketogenic diet in overweight and obese men. Am J Clin Nutr. 2016 Aug;104(2):324-33. doi: 10.3945/ajcn.116.133561. Epub 2016 Jul 6.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. demographics, anthropometrics, indirect calorimetry data, circulating metabolites and hormones
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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.
Stephanie T Chung, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Diet, Ketogenic Diet and Nicotinamide Riboside in people with Overweight and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nan Zhai, C.R.N.P. ((301) 827-3324, nan.zhai@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT06044935, 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 18 Sep 2026.