Measuring Sugar Intake Using Stable Isotopes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve dietary assessment methods by using stable isotopes to accurately measure sugar intake in healthy adults. Participants will be fed controlled diets for 13 weeks while their blood, urine, and hair samples are analyzed for stable isotope ratios. The primary goal is to validate stable isotope biomarkers as reliable indicators of specific dietary patterns, particularly focusing on sugar consumption from soda. Secondary objectives include examining the effects of different sugar intake levels on various biological markers.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• NIDDK, Phoenix
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Susanne M Votruba, Ph.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study coordinator: Susanne M Votruba, Ph.D.
• Email: votrubas@mail.nih.gov
• Phone: (602) 200-5336

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.