RECRUITING

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

Conditions

Diet Therapy Healthy Volunteers Biomarkers Stable Isotopes Dietary Intake

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-23

Study Completion:2028-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04799301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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. * Non-English speaking * Inability of participant to understand and the unwillingness to sign a written informed consent document.

Inclusion Criteria

Exclusion 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.

* 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.
* Non-English speaking
* Inability of participant to understand and the unwillingness to sign a written informed consent document.

Contacts and Locations

Study Contact

Susi M Votruba, Ph.D.

CONTACT

(602) 200-5336

votrubas@niddk.nih.gov

Principal Investigator

Susi M Votruba, Ph.D.

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

NIDDK, Phoenix

Phoenix, Arizona, 85014

United States

Collaborators and Investigators

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

Susi M Votruba, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-23

Study Completion Date2028-01-01

Study Record Updates

Study Start Date2022-02-23

Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

Biomarkers
Stable Isotopes
Dietary Intake

Additional Relevant MeSH Terms

Diet Therapy
Healthy Volunteers