Soda science: new biomarkers could track your sugar intake without Self-Reporting
NCT ID NCT04799301
First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 8 times
Summary
This study aims to find better ways to measure what people eat, specifically sugar from soda. Researchers will have 60 healthy adults live in a clinic for 13 weeks, eating controlled diets with different amounts of soda. They will then test if stable isotopes in blood, hair, and other samples can accurately reflect how much sugar was consumed. The goal is to develop objective biomarkers that could replace unreliable self-reported diet data in future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- diet with controlled soda intake
- What this could lead to
- If successful, this could provide a more accurate way to measure sugar intake in research, helping scientists better understand diet's role in chronic diseases.
- What could go wrong
- This is an early-phase study with only 60 healthy volunteers, so results may not apply to the general population. The biomarkers may not prove reliable enough for widespread use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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 * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NIDDK, Phoenix
RECRUITINGPhoenix, Arizona, 85014, United States
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