Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04799301|
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : November 8, 2022
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.
To see if stable isotopes can help scientists identify things people eat.
Healthy adults ages 18 to 65
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.
|Condition or disease||Intervention/treatment||Phase|
|Diet Therapy Healthy Volunteers||Behavioral: Diet with no soda Behavioral: Diet with 50% of carb intake from soda Behavioral: Diet with 20% of carb intake from soda||Phase 1|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake|
|Actual Study Start Date :||February 23, 2022|
|Estimated Primary Completion Date :||January 1, 2028|
|Estimated Study Completion Date :||January 1, 2028|
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.
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
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.
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
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.
Behavioral: Diet with no soda
Weight-maintaining diet without soda, with all carbohydrates originating from sources other than corn and sugar cane
- Change in the blood carbon stable isotope ratio (13C/12C) from baseline to 12 weeks. [ Time Frame: Baseline, Week 8, Week 10, Week 12 ]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.
- Change in the hair carbon stable isotope ratio (13C/12C) from baseline to 12 weeks. [ Time Frame: Baseline, Week 12 ]We will test biomarker diet relationships at baseline and 12 weeks to determine differences in values over time and dose.
- Change in the carbon stable isotope ratio of alanine from baseline to 12 weeks. [ Time Frame: Baseline, every two weeks through Week 12 ]We will examine the time response of CIR-alanine. We will use a difference of 1.5 (Infinite) (+/-) from baseline as a preliminary criterion and adjust to ensure balanced representation of treatments in the 'time response' subset of participants. From these participants we will measure CIR-alanine at all timepoints. We will assess temporal change in CIR- alanine by examining week-to-week correlations to identify the time point at which biomarker measurements become independent of baseline, and by using linear mixed models to model the longitudinal trends over time.
- Change in urinary sucrose/fructose over time and with varying levels of SSB intake. [ Time Frame: Baseline, every two weeks through Week 12 ]Repeated measures two-way ANOVA will be employed to assess the between-subjects effect and to compare the daily sugars excretion during different levels of sugars intake.
- 24h EE and its components from the metabolic chamber. [ Time Frame: Baseline, Week 1, Week 12 ]Diet-induced changes in EE will be assessed for significance using a paired t test (before/after intervention) and ANCOVA (dose).
- To determine the effect of dietary changes on the microbiome of the gut, single stool samples will be collected upon admission and completion. [ Time Frame: Baseline, Week 12 ]We will measure 16s rRNA on stool samples before and after dietary intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799301
|Contact: Susanne Votruba, Ph.D.||(602) email@example.com|
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Principal Investigator:||Susanne Votruba, Ph.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|