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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT04799301
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diet Therapy
  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 23, 2022
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Diet with 20% of carb intake from soda
    This group will receive a weight-maintaining diet with 20% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply.
  • Experimental: Diet with 50% of carb intake from soda
    This group will receive a weight-maintaining diet with 50% of carbohydrates provided as soda. The carbohydrates from sources other than corn and sugar cane will be reduced accordingly to meet the total carbohydrate supply.
  • Experimental: Diet with no soda
    This group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane.

Primary Outcome Measure

Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks. [ Time Frame: Baseline, Week 8, Week 10, Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIDDK, PhoenixPhoenixArizona85014
Susi Votruba
[email protected]
602-200-5336

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