NCT04799301

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Diet Therapy
• Healthy Volunteers

Interventions

Type	Name	Description
BEHAVIORAL	Diet with no soda	Weight-maintaining diet without soda, with all carbohydrates originating from sources other than corn and sugar cane
BEHAVIORAL	Diet with 50% of carb intake from soda	Weight-maintaining diet with 50% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane
BEHAVIORAL	Diet with 20% of carb intake from soda	Weight-maintaining diet with 20% of carbohydrates provided as soda, and all other carbohydrates originating from sources other than corn and sugar cane

Timeline

• Start date: 2022-02-23
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2021-03-16
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States