Developing Biomarkers of Dietary Intake

Summary

Background:

\- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake.

Objectives:

\- To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda).

Eligibility:

\- Healthy, nondiabetic men between 18 and 65 years of age.

Design:

* This study involves an initial screening visit and a 12-13 week inpatient dietary study period.
* Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes.
* After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests.
* Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism.
* Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period.
* At the end of the 12-week study diet period, participants will provide additional hair, blood, and fat tissue samples, and will have a second metabolism assessment in the metabolic chamber.

Conditions

• Diet Therapy
• Healthy Volunteers

Interventions

OTHER

7. No meat, fish or soda

weight maintaining diet with no meat, no fish, and no soda (vegetarian)

OTHER

8. Soda, no meat or fish

weight maintaining diet with soda but no meat or fish (vegetarian + soda)

OTHER

3. Meat and fish, no soda

weight maintaining diet with meat and fish but no soda

OTHER

4. Meat and fish and soda

weight maintaining diet with meat, fish and soda

OTHER

5. Fish, no meat or soda

weight maintaining diet with fish but no meat or soda

OTHER

6. Fish and soda, no meat

weight maintaining diet with fish and soda but no meat

OTHER

2. Meat and soda, no fish

weight maintaining diet with meat and soda but no fish

OTHER

1. Meat, no fish or soda

weight maintaining diet with meat but no fish or soda

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Susanne M Votruba, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-24

Primary Completion

2020-03-31

Completion

2020-03-31

Countries

• United States

Study Locations