Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 11-DK-N018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Studies of health and nutrition use a variety of tools to determine what people eat from day to day. Unfortunately, most of the methods used are not accurate for a variety of reasons and do not provide solid information on which to base health recommendations or public policy. In general, when people are asked to keep track of what they eat or recall what they have eaten in the past, they make mistakes in estimating both amounts and specifics of what was eaten. New tools that can help determine if people are accurately remembering what they ate are desperately needed.
Biomarkers are things that can be measured (in urine, blood, hair, etc.) which are related to the intake of a particular food in a consistent way and may therefore be more accurate than a food record. One set of biomarkers that may be used are naturally occurring (present in all foods) stable isotopes of carbon and nitrogen to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. These isotopes can be measured in blood samples and hair.
The aim of this study is to validate the use of stable isotope biomarkers as representative of specific dietary intake patterns (meat/fish/soda). This study will be an inpatient study in which highly specific diets will be fed to volunteers for ~12 weeks and stable isotopes will be measured in blood and hair. The ultimate goal is to develop biomarkers to be used to validate food intake patterns in outpatient clinical and epidemiological studies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Meat, no fish or soda | Experimental | weight maintaining diet with meat but no fish or soda for 12 weeks |
|
| 2. Meat and soda, no fish | Experimental | weight maintaining diet with meat and soda but no fish for 12 weeks |
|
| 4. Meat and fish and soda | Experimental | weight maintaining diet with meat, fish, and soda for 12 weeks |
|
| 5. Fish, no meat or soda | Experimental | weight maintaining diet with meat, fish, and soda for 12 weeks |
|
| 6. Fish and soda, no meat | Experimental | weight maintaining diet with fish and soda but no meat for 12 weeks |
|
| 7. No meat, fish, or soda | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. Meat, no fish or soda | Other | weight maintaining diet with meat but no fish or soda |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIR | Change in nitrogen stable isotope rations (N15/N14) | Weeks 0, 2, 4, 6, 8, 10, 12 |
| Change in CR | Change in carbon stable isotope ratios (13C/12C) | Weeks 0, 2, 4, 6, 8, 10, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance tests | Iowa Card Setting Test, Stroop Color Word Test, Wisconsin Card Sorting Test, Go/No Go Task | Weeks 0 and 12 |
| OGTT | Weeks 0 and 12 |
Not provided
Healthy, as determined by medical history, physical examination, and laboratory tests.
EXCLUSION CRITERIA:
Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study.
Non-English speaking subjects as a population will be excluded from participation in this protocol. One of the secondary hypotheses of the protocol relates to a battery of psychological questionnaires and performances tests which are administered to the volunteers at the beginning and end of the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore we will restrict enrollment to English speaking subjects only.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susanne M Votruba, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIDDK, Phoenix | Phoenix | Arizona | 85014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12835281 | Background | Kipnis V, Subar AF, Midthune D, Freedman LS, Ballard-Barbash R, Troiano RP, Bingham S, Schoeller DA, Schatzkin A, Carroll RJ. Structure of dietary measurement error: results of the OPEN biomarker study. Am J Epidemiol. 2003 Jul 1;158(1):14-21; discussion 22-6. doi: 10.1093/aje/kwg091. | |
| 12835280 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
no fish, and no soda (vegetarian) for 12 weeks
|
| 8. Soda, no meart or fish | Experimental | weight maintaining diet with soda but no meat or fish (vegetarian + soda) for 12 weeks |
|
| Meat and fish, no soda | Experimental | weight maintaining diet with meat and fish but no soda for 12 weeks |
|
| 2. Meat and soda, no fish | Other | weight maintaining diet with meat and soda but no fish |
|
| 3. Meat and fish, no soda | Other | weight maintaining diet with meat and fish but no soda |
|
| 4. Meat and fish and soda | Other | weight maintaining diet with meat, fish and soda |
|
| 5. Fish, no meat or soda | Other | weight maintaining diet with fish but no meat or soda |
|
| 6. Fish and soda, no meat | Other | weight maintaining diet with fish and soda but no meat |
|
| 7. No meat, fish or soda | Other | weight maintaining diet with no meat, no fish, and no soda (vegetarian) |
|
| 8. Soda, no meat or fish | Other | weight maintaining diet with soda but no meat or fish (vegetarian + soda) |
|
| Lipid panel | LDL, HDL, Triglycerides and Total Cholesterol | Weeks 0 and 12 |
| Respiratory quotient (RQ) | Ratio of the volume of carbon dioxide (CO2) produced to the volume of oxygen (O2) used, or VCO2/VO2 | Weeks 0 and 12 |
| Subar AF, Kipnis V, Troiano RP, Midthune D, Schoeller DA, Bingham S, Sharbaugh CO, Trabulsi J, Runswick S, Ballard-Barbash R, Sunshine J, Schatzkin A. Using intake biomarkers to evaluate the extent of dietary misreporting in a large sample of adults: the OPEN study. Am J Epidemiol. 2003 Jul 1;158(1):1-13. doi: 10.1093/aje/kwg092. |
| 1877501 | Background | Tarasuk V, Beaton GH. The nature and individuality of within-subject variation in energy intake. Am J Clin Nutr. 1991 Sep;54(3):464-70. doi: 10.1093/ajcn/54.3.464. |
| 41047130 | Derived | Johnson JJ, Ghosh S, Shaw PA, Neuhouser ML, Lampe JW, Tinker LF, Prentice RL, Tasevska N, Freedman LS, Boyer BB, Hopkins SE, Nash SH, Votruba SB, Krakoff J, O'Brien DM. The carbon isotope ratio of alanine is a biomarker of added sugar and sugar-sweetened beverage intakes: a pooled analysis of 4 studies. Am J Clin Nutr. 2025 Dec;122(6):1769-1777. doi: 10.1016/j.ajcnut.2025.09.049. Epub 2025 Oct 3. |
| 36095134 | Derived | Mitchell CM, Oxtoby LE, Shaw PA, Budge SM, Wooller MJ, Cabeza de Baca T, Krakoff J, Votruba S, O'Brien DM. Carbon Isotope Ratios of Plasma and RBC Fatty Acids Identify Meat Consumers in a 12-Week Inpatient Feeding Study of 32 Men. J Nutr. 2023 Jan 14;152(12):2847-2855. doi: 10.1093/jn/nxac213. |
| 35511610 | Derived | Johnson JJ, Shaw PA, Wooller MJ, Venti CA, Krakoff J, Votruba SB, O'Brien DM. Amino Acid Nitrogen Isotope Ratios Respond to Fish and Meat Intake in a 12-Week Inpatient Feeding Study of Men. J Nutr. 2022 Sep 6;152(9):2031-2038. doi: 10.1093/jn/nxac101. |
| 33938613 | Derived | Mitchell CM, Piaggi P, O'Brien DM, Krakoff J, Votruba SB. Metabolic Characterization of Meat, Fish, and Soda Intake in Males: Secondary Results from a Randomized Inpatient Pilot Study. Obesity (Silver Spring). 2021 Jun;29(6):995-1002. doi: 10.1002/oby.23167. Epub 2021 May 3. |
| 33676366 | Derived | Johnson JJ, Shaw PA, Oh EJ, Wooller MJ, Merriman S, Yun HY, Larsen T, Krakoff J, Votruba SB, O'Brien DM. The carbon isotope ratios of nonessential amino acids identify sugar-sweetened beverage (SSB) consumers in a 12-wk inpatient feeding study of 32 men with varying SSB and meat exposures. Am J Clin Nutr. 2021 May 8;113(5):1256-1264. doi: 10.1093/ajcn/nqaa374. |
| 31515553 | Derived | Votruba SB, Shaw PA, Oh EJ, Venti CA, Bonfiglio S, Krakoff J, O'Brien DM. Associations of plasma, RBCs, and hair carbon and nitrogen isotope ratios with fish, meat, and sugar-sweetened beverage intake in a 12-wk inpatient feeding study. Am J Clin Nutr. 2019 Dec 1;110(6):1306-1315. doi: 10.1093/ajcn/nqz208. |
| 30651576 | Derived | Stinson EJ, Graham AL, Thearle MS, Gluck ME, Krakoff J, Piaggi P. Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure. Int J Obes (Lond). 2019 Jul;43(7):1456-1465. doi: 10.1038/s41366-018-0305-9. Epub 2019 Jan 16. |
| ID | Term |
|---|---|
| D017404 | In Situ Hybridization, Fluorescence |
| ID | Term |
|---|---|
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
Not provided
Not provided