Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04799301

Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

60

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index less than or equal to 35 kg/m² to minimize impact on isotope measurements
  • Men and women aged 18 to 65 years
  • Healthy as determined by medical history, physical exam, and laboratory tests
Not Eligible

You will not qualify if you...

  • Fasting plasma glucose greater than or equal to 126 mg/dL
  • Alopecia totalis or inability to grow at least one inch of hair
  • Use of metabolism or appetite-affecting medication in the last 3 months
  • Dietary restrictions limiting ability to consume assigned diet
  • Current pregnancy, pregnancy within past 6 months, or lactating
  • History or signs of acute or chronic disorders affecting appetite or energy expenditure
  • Gastrointestinal diseases or malabsorption syndromes affecting metabolism or absorption
  • Unstable medical conditions such as hepatitis, renal insufficiency, or recent cancer treatment
  • Diagnosis of binge eating disorder, anorexia nervosa, or bulimia nervosa
  • Alcohol abuse as indicated by AUDIT score ≥8
  • Tobacco use with dependence score greater than 2
  • Use of drugs like amphetamines, cocaine, or heroin
  • Weight change of plus or minus 5% in last 3 months
  • Non-English speaking
  • Inability to understand or unwillingness to sign informed consent
  • Any other condition deemed unsafe or interfering by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

NIDDK, Phoenix

Phoenix, Arizona, United States, 85014

Actively Recruiting

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Research Team

S

Susanne M Votruba, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake | DecenTrialz