Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diet Therapy
  • Healthy Volunteers
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 and hair. Participants will be randomized to one of three diets: a weight-maintaining diet without soda, a weight maintaining diet w...

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 and hair. Participants will be randomized to one of three diets: a weight-maintaining diet without soda, a weight maintaining diet with 20% of carbohydrates provided as soda, and a weight maintaining diet with 40% of carbohydrates provided as soda. Ultimately, the goal is to develop biomarkers to be used to validate food intake patterns in outpatient clinical and epidemiological studies. The primary objective of this study is to validate the use of stable isotope biomarkers as representatives of specific dietary intake patterns; changes in the blood and hair carbon stable isotope ratio (13C/12C) will be measured from baseline to 12 weeks. 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, measured from baseline to 12 weeks. Study volunteers will be adult non-diabetic men and women who are in good health.

Tracking Information

NCT #
NCT04799301
Collaborators
Not Provided
Investigators
Principal Investigator: Susanne Votruba, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)