Diet TherapyPhase 1NCT04799301
Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
A Phase 1 study testing Diet with no soda, Diet with 50% of carb intake from soda and Diet with 20% of carb intake from soda in people with Diet Therapy and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Therapy, Healthy Volunteers
- What is being tested?
- Diet with no soda, Diet with 50% of carb intake from soda and Diet with 20% of carb intake from soda
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 1 Jan 2028
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- 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:
- Body mass index less than or equal to 35 kg/m^2 to minimize the impact of body size on isotope measurements.
- Women and men between the ages of 18-65 years will be recruited for this study
- Healthy, as determined by medical history, physical examination, and laboratory tests.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Fasting plasma glucose greater than or equal to 126 mg/dL
- Alopecia totalis or inability to grow hair (at least one inch of hair required to obtain sample)
- Use of medication affecting metabolism and appetite in the last three months
- Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized
- Current pregnancy, pregnancy within the past 6 months or currently lactating
Show all 19Show fewer
- History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or EE, (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses)
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food
- Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years (except for nonmelanoma skin cancers or cancers that have clearly been cured), or central nervous system disorders etc. as assessed by history and physical exam
- Diagnosis of binge eating disorder, anorexia-nervosa, or bulimia-nervosa
- Evidence of alcohol abuse as defined by greater than or equal to 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults
- Current use of tobacco products that exceed Low Dependence on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2)
- Current use of drugs such as amphetamines, cocaine, or heroin
- Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.
- Weight change of plus or minus 5% in the last 3 months, per self report.
- Non-English speaking
- Inability of participant to understand and the unwillingness to sign a written informed consent document.
- Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study.
- Non-English-speaking subjects as a population will be excluded from participation in this protocol. One of the secondary hypotheses of the protocol relates to a battery of psychological questionnaires and performances tests which are administered to the volunteers at the beginning and end of the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.
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
NIDDK, Phoenix
Phoenix, Arizona, 85014
Susi Votruba, 602-200-5336, susi.votruba@nih.gov
About this study
Background:
Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat.
Read more
Objective:
To see if stable isotopes can help scientists identify things people eat.
Eligibility:
Healthy adults ages 18 to 65
Design:
Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study.
Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks.
For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda.
Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays.
Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours.
Participants will give hair and stool samples.
Participants will complete a diet questionnaire. It assesses their food intake over 24 hours.
Participants will complete behavioral questionnaires and computer performance tests.
Participants will have fat biopsies taken from their stomach and thigh.
Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.
Read the detailed description
Study Description:
This study will be an inpatient study in which highly specific diets will be fed to volunteers for approximately 12 weeks and stable isotopes will be measured in blood, hair, and adipose. Ultimately, the goal is to develop biomarkers to be used to validate food intake patterns in outpatient clinical and epidemiological studies.
Objectives:
The primary objective of this study is to validate the use of stable isotope biomarkers as representatives of specific dietary intake patterns.
Secondary objectives include evaluation of the effect of the amount of soda on urinary sucrose and fructose excretion, extracellular vesicles levels and content, and gut microbiota.
Endpoints (Outcomes):
Primary Endpoints: Primary Endpoints: Changes in the blood, hair, and adipose carbon (13C/12C) and nitrogen (15N/14N) stable isotope ratio from baseline to 12 weeks.
Secondary Endpoints: Changes in urinary sucrose and fructose excretion, extracellular vesicles levels and content, gut microbiota from baseline to 12 weeks.
- Conditions
- Diet Therapy, Healthy Volunteers
- Being tested
- Diet with no soda, Diet with 50% of carb intake from soda, Diet with 20% of carb intake from soda
- Keywords
- Biomarkers, Stable Isotopes, Dietary Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with no sodaBehavioural
Weight-maintaining diet without soda, with all carbohydrates originating from sources other than corn and sugar cane
Diet with 50% of carb intake from sodaBehavioural
Weight-maintaining diet with 50% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane
Diet with 20% of carb intake from sodaBehavioural
Weight-maintaining diet with 20% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane
| Study group | Role | What they receive |
|---|---|---|
| Diet with 20% of carb intake from soda | Experimental | This group will receive a weight-maintaining diet with 20% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply. Receives: Behavioral: Diet with 20% of carb intake from soda |
| Diet with 50% of carb intake from soda | Experimental | This group will receive a weight-maintaining diet with 50% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply. Receives: Behavioral: Diet with 50% of carb intake from soda |
| Diet with no soda | Experimental | This group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane. Receives: Behavioral: Diet with no soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
We will test biomarker diet relationships at the week 8, 10 and 12 sampling time points, using linear mixed effects models to evaluate single CIR biomarkers of SSB in plasma. Specifically, we will also test the time x group interaction by including it as a fixed effect in the mixed model analysis to evaluate the differences in the rate of CIR change over time across groups. Baseline CIR will be included as covariate in the mixed model analysis.
Measured: Baseline, Week 8, Week 10, Week 12
Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
We will test biomarker diet relationships at baseline and 12 weeks to determine differences in values over time and dose.
Measured: Baseline, Week 12
Secondary outcomes (4)
Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks.
We will examine the time response of CIR-alanine. We will use a difference of 1.5 (Infinite) (+/-) from baseline as a preliminary criterion and adjust to ensure balanced representation of treatments in the 'time response' subset of participants. From these participants we will measure CIR-alanine at all timepoints. We will assess temporal change in CIR- alanine by examining week-to-week correlations to identify the time point at which biomarker measurements become independent of baseline, and by using linear mixed models to model the longitudinal trends over time.
Measured: Baseline, every two weeks through Week 12
Change in urinary sucrose/fructose over time and with varying levels of SSB intake.
Repeated measures two-way ANOVA will be employed to assess the between-subjects effect and to compare the daily sugars excretion during different levels of sugars intake.
Measured: Baseline, every two weeks through Week 12
24h EE and its components from the metabolic chamber.
Diet-induced changes in EE will be assessed for significance using a paired t test (before/after intervention) and ANCOVA (dose).
Measured: Baseline, Week 1, Week 12
To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be collected upon admission and completion.
We will measure 16s rRNA on stool samples before and after dietary intervention.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start23 Feb 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet TherapyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susanne M Votruba, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799301
- Sponsor's protocol ID
- 10000043
- Other IDs
- 000043-DK
- Status last verified
- 26 Aug 2026
- First submitted
- 13 Mar 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
- ClinicalTrials.gov ID
- NCT04799301
- Acronym / sponsor ID
- 10000043
- Conditions
- Diet Therapy, Healthy Volunteers
- Keywords
- Biomarkers, Stable Isotopes, Dietary Intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Mar 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.
Background:
Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat.
Objective:
To see if stable isotopes can help scientists identify things people eat.
Eligibility:
Healthy adults ages 18 to 65
Design:
Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study.
Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks.
For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda.
Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays.
Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours.
Participants will give hair and stool samples.
Participants will complete a diet questionnaire. It assesses their food intake over 24 hours.
Participants will complete behavioral questionnaires and computer performance tests.
Participants will have fat biopsies taken from their stomach and thigh.
Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.
Detailed description
Study Description:
This study will be an inpatient study in which highly specific diets will be fed to volunteers for approximately 12 weeks and stable isotopes will be measured in blood, hair, and adipose. Ultimately, the goal is to develop biomarkers to be used to validate food intake patterns in outpatient clinical and epidemiological studies.
Objectives:
The primary objective of this study is to validate the use of stable isotope biomarkers as representatives of specific dietary intake patterns.
Secondary objectives include evaluation of the effect of the amount of soda on urinary sucrose and fructose excretion, extracellular vesicles levels and content, and gut microbiota.
Endpoints (Outcomes):
Primary Endpoints: Primary Endpoints: Changes in the blood, hair, and adipose carbon (13C/12C) and nitrogen (15N/14N) stable isotope ratio from baseline to 12 weeks.
Secondary Endpoints: Changes in urinary sucrose and fructose excretion, extracellular vesicles levels and content, gut microbiota from baseline to 12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet with 20% of carb intake from soda | Experimental | Behavioral: Diet with 20% of carb intake from sodaThis group will receive a weight-maintaining diet with 20% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply. |
| Diet with 50% of carb intake from soda | Experimental | Behavioral: Diet with 50% of carb intake from sodaThis group will receive a weight-maintaining diet with 50% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply. |
| Diet with no soda | Experimental | Behavioral: Diet with no sodaThis group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Body mass index less than or equal to 35 kg/m^2 to minimize the impact of body size on isotope measurements.
- Women and men between the ages of 18-65 years will be recruited for this study
- Healthy, as determined by medical history, physical examination, and laboratory tests.
Key exclusion criteria (19 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Fasting plasma glucose greater than or equal to 126 mg/dL
- Alopecia totalis or inability to grow hair (at least one inch of hair required to obtain sample)
- Use of medication affecting metabolism and appetite in the last three months
- Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized
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 |
|---|---|---|
| Diet with no sodaWeight-maintaining diet without soda, with all carbohydrates originating from sources other than corn and sugar cane | Behavioural | Diet with no soda |
| Diet with 50% of carb intake from sodaWeight-maintaining diet with 50% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane | Behavioural | Diet with 50% of carb intake from soda |
| Diet with 20% of carb intake from sodaWeight-maintaining diet with 20% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane | Behavioural | Diet with 20% of carb intake from soda |
Primary outcome
Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
Time frame: Baseline, Week 8, Week 10, Week 12
We will test biomarker diet relationships at the week 8, 10 and 12 sampling time points, using linear mixed effects models to evaluate single CIR biomarkers of SSB in plasma. Specifically, we will also test the time x group interaction by including it as a fixed effect in the mixed model analysis to evaluate the differences in the rate of CIR change over time across groups. Baseline CIR will be included as covariate in the mixed model analysis.
Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.
Time frame: Baseline, Week 12
We will test biomarker diet relationships at baseline and 12 weeks to determine differences in values over time and dose.
4 secondary outcomes
Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks.
Time frame: Baseline, every two weeks through Week 12
Change in urinary sucrose/fructose over time and with varying levels of SSB intake.
Time frame: Baseline, every two weeks through Week 12
24h EE and its components from the metabolic chamber.
Time frame: Baseline, Week 1, Week 12
To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be collected upon admission and completion.
Time frame: Baseline, Week 12
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 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Healthy Volunteers
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.
Susanne M Votruba, Ph.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 Phase 1 study testing Diet with no soda, Diet with 50% of carb intake from soda and Diet with 20% of carb intake from soda in people with Diet Therapy and Healthy Volunteers, 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 4 inclusion and 19 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 16 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Susanne M Votruba, Ph.D. ((602) 200-5336, votrubas@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks. (time frame: Baseline, Week 8, Week 10, Week 12). 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?
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 16 Oct 2026.