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

NCT04799301 | Recruiting Phase 1

• 2 other identifiers: 10000043000043-DK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diet Therapy; Healthy Volunteers

Keywords

Biomarkers; Stable Isotopes; Dietary Intake

Outcome Measures

Primary Outcomes (2)

• Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.

  We will test biomarker diet relationships at the week 8, 10 and 12 sampling time points, using linear mixed effects models to evaluate single CIR biomarkers of SSB in plasma. Specifically, we will also test the time x group interaction by including it as a fixed effect in the mixed model analysis to evaluate the differences in the rate of CIR change over time across groups. Baseline CIR will be included as covariate in the mixed model analysis.

  Baseline, Week 8, Week 10, Week 12

• Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks.

  We will test biomarker diet relationships at baseline and 12 weeks to determine differences in values over time and dose.

  Baseline, Week 12

Secondary Outcomes (4)

• Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks.

  Baseline, every two weeks through Week 12

• Change in urinary sucrose/fructose over time and with varying levels of SSB intake.

  Baseline, every two weeks through Week 12

• 24h EE and its components from the metabolic chamber.

  Baseline, Week 1, Week 12

• To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be collected upon admission and completion.

  Baseline, Week 12

Study Arms (3)

Diet with 20% of carb intake from soda

EXPERIMENTAL

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.

Behavioral: Diet with 20% of carb intake from soda

Diet with 50% of carb intake from soda

EXPERIMENTAL

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.

Behavioral: Diet with 50% of carb intake from soda

Diet with no soda

EXPERIMENTAL

This group will receive a weight-maintaining diet without soda. All 50% of carbohydrates will originate from sources other than corn and sugar cane.

Behavioral: Diet with no soda

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 no soda

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 50% of carb intake from soda

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

Diet with 20% of carb intake from soda

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Susanne M Votruba, Ph.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne M Votruba, Ph.D.

CONTACT

(301) 827-3521; votrubas@niddk.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 16, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02-11

Locations

US (1)