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Soda science: new biomarkers could track your sugar intake without Self-Reporting

NCT ID NCT04799301

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • NIDDK, Phoenix

    RECRUITING

    Phoenix, Arizona, 85014, United States

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