Diet TherapyPhase 1NCT01237093
Developing Biomarkers of Dietary Intake
A Phase 1 study testing 1. Meat, no fish or soda, 2. Meat and soda, no fish and 3. Meat and fish, no soda in people with Diet Therapy and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Diet Therapy, Healthy Volunteers
- What is being tested?
- 1. Meat, no fish or soda, 2. Meat and soda, no fish and 3. Meat and fish, no soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2010to 31 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index less than or equal to 35 kg/m(2) to minimize the impact of body size on isotope measurements.
- Males 18-65 years old will be recruited for this study. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.
- Healthy, as determined by medical history, physical examination, and laboratory tests.
Who cannot join
- Current smoking
- Female sex
- Baldness or hair less than 2 cm in length
- Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized.
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo- and hyperthyroidism)
Show all 20Show fewer
- Chronic pulmonary disorders, including chronic obstructive pulmonary disease, that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry).
- Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease)
- Hypertension (blood pressure measurement higher than 140/90 mm Hg on two or more occasions or use of anti-hypertensive medications)
- Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study
- Presence of a pacemaker or other implantable devices
- Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 x normal)
- Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or greater than 100mg/dl of protein based on urine dipstick)
- Central nervous system disease (cerebrovascular accidents, dementia, and neurodegenerative disorders)
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
- Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana)
- Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder
- Weight change of plus or minus 5% in the last 3 months
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Diet Therapy, Healthy Volunteers
- Being tested
- 1. Meat, no fish or soda, 2. Meat and soda, no fish, 3. Meat and fish, no soda, 4. Meat and fish and soda, 5. Fish, no meat or soda
- Keywords
- Fish Diet, Meat Diet, Biomarkers, Stable Isotopes, Dietary Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Meat, no fish or sodaOther
weight maintaining diet with meat but no fish or soda
2. Meat and soda, no fishOther
weight maintaining diet with meat and soda but no fish
3. Meat and fish, no sodaOther
weight maintaining diet with meat and fish but no soda
4. Meat and fish and sodaOther
weight maintaining diet with meat, fish and soda
5. Fish, no meat or sodaOther
weight maintaining diet with fish but no meat or soda
6. Fish and soda, no meatOther
weight maintaining diet with fish and soda but no meat
7. No meat, fish or sodaOther
weight maintaining diet with no meat, no fish, and no soda (vegetarian)
8. Soda, no meat or fishOther
weight maintaining diet with soda but no meat or fish (vegetarian + soda)
| Study group | Role | What they receive |
|---|---|---|
| 1. Meat, no fish or soda | Experimental | weight maintaining diet with meat but no fish or soda for 12 weeks Receives: Other: 1. Meat, no fish or soda |
| 2. Meat and soda, no fish | Experimental | weight maintaining diet with meat and soda but no fish for 12 weeks Receives: Other: 2. Meat and soda, no fish |
| 4. Meat and fish and soda | Experimental | weight maintaining diet with meat, fish, and soda for 12 weeks Receives: Other: 4. Meat and fish and soda |
| 5. Fish, no meat or soda | Experimental | weight maintaining diet with meat, fish, and soda for 12 weeks Receives: Other: 5. Fish, no meat or soda |
| 6. Fish and soda, no meat | Experimental | weight maintaining diet with fish and soda but no meat for 12 weeks Receives: Other: 6. Fish and soda, no meat |
| 7. No meat, fish, or soda | Experimental | no fish, and no soda (vegetarian) for 12 weeks Receives: Other: 7. No meat, fish or soda |
| 8. Soda, no meart or fish | Experimental | weight maintaining diet with soda but no meat or fish (vegetarian + soda) for 12 weeks Receives: Other: 8. Soda, no meat or fish |
| Meat and fish, no soda | Experimental | weight maintaining diet with meat and fish but no soda for 12 weeks Receives: Other: 3. Meat and fish, no soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIR
Change in nitrogen stable isotope rations (N15/N14)
Measured: Weeks 0, 2, 4, 6, 8, 10, 12
Change in CR
Change in carbon stable isotope ratios (13C/12C)
Measured: Weeks 0, 2, 4, 6, 8, 10, 12
Secondary outcomes (4)
Performance tests
Iowa Card Setting Test, Stroop Color Word Test, Wisconsin Card Sorting Test, Go/No Go Task
Measured: Weeks 0 and 12
OGTT
Measured: Weeks 0 and 12
Lipid panel
LDL, HDL, Triglycerides and Total Cholesterol
Measured: 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
Measured: Weeks 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study start24 Oct 2010
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diet TherapyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susanne M Votruba, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237093
- Sponsor's protocol ID
- 999911018
- Other IDs
- 11-DK-N018
- Status last verified
- 16 Mar 2026
- First submitted
- 6 Nov 2010
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12835281Subar 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.
PubMed 12835280Tarasuk 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.
PubMed 1877501Johnson 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.
PubMed 41047130Mitchell 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.
PubMed 36095134Johnson 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.
PubMed 35511610Mitchell 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.
PubMed 33938613Johnson 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.
PubMed 33676366Votruba 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.
PubMed 31515553Stinson 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.
PubMed 30651576
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Biomarkers of Dietary Intake
- ClinicalTrials.gov ID
- NCT01237093
- Acronym / sponsor ID
- 999911018
- Conditions
- Diet Therapy, Healthy Volunteers
- Keywords
- Fish Diet, Meat Diet, Biomarkers, Stable Isotopes, Dietary Intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 24 Oct 2010
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1. Meat, no fish or soda | Experimental | Other: 1. Meat, no fish or sodaweight maintaining diet with meat but no fish or soda for 12 weeks |
| 2. Meat and soda, no fish | Experimental | Other: 2. Meat and soda, no fishweight maintaining diet with meat and soda but no fish for 12 weeks |
| 4. Meat and fish and soda | Experimental | Other: 4. Meat and fish and sodaweight maintaining diet with meat, fish, and soda for 12 weeks |
| 5. Fish, no meat or soda | Experimental | Other: 5. Fish, no meat or sodaweight maintaining diet with meat, fish, and soda for 12 weeks |
| 6. Fish and soda, no meat | Experimental | Other: 6. Fish and soda, no meatweight maintaining diet with fish and soda but no meat for 12 weeks |
| 7. No meat, fish, or soda | Experimental | Other: 7. No meat, fish or sodano fish, and no soda (vegetarian) for 12 weeks |
| 8. Soda, no meart or fish | Experimental | Other: 8. Soda, no meat or fishweight maintaining diet with soda but no meat or fish (vegetarian + soda) for 12 weeks |
| Meat and fish, no soda | Experimental | Other: 3. Meat and fish, no sodaweight maintaining diet with meat and fish but no soda for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index less than or equal to 35 kg/m(2) to minimize the impact of body size on isotope measurements.
- Males 18-65 years old will be recruited for this study. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.
- Healthy, as determined by medical history, physical examination, and laboratory tests.
Key exclusion criteria (20 listed)
- Current smoking
- Female sex
- Baldness or hair less than 2 cm in length
- Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized.
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Meat, no fish or sodaweight maintaining diet with meat but no fish or soda | Other | 1. Meat, no fish or soda |
| 2. Meat and soda, no fishweight maintaining diet with meat and soda but no fish | Other | 2. Meat and soda, no fish |
| 3. Meat and fish, no sodaweight maintaining diet with meat and fish but no soda | Other | Meat and fish, no soda |
| 4. Meat and fish and sodaweight maintaining diet with meat, fish and soda | Other | 4. Meat and fish and soda |
| 5. Fish, no meat or sodaweight maintaining diet with fish but no meat or soda | Other | 5. Fish, no meat or soda |
| 6. Fish and soda, no meatweight maintaining diet with fish and soda but no meat | Other | 6. Fish and soda, no meat |
| 7. No meat, fish or sodaweight maintaining diet with no meat, no fish, and no soda (vegetarian) | Other | 7. No meat, fish, or soda |
| 8. Soda, no meat or fishweight maintaining diet with soda but no meat or fish (vegetarian + soda) | Other | 8. Soda, no meart or fish |
Primary outcome
Change in NIR
Time frame: Weeks 0, 2, 4, 6, 8, 10, 12
Change in nitrogen stable isotope rations (N15/N14)
Change in CR
Time frame: Weeks 0, 2, 4, 6, 8, 10, 12
Change in carbon stable isotope ratios (13C/12C)
4 secondary outcomes
Performance tests
Time frame: Weeks 0 and 12
OGTT
Time frame: Weeks 0 and 12
Lipid panel
Time frame: Weeks 0 and 12
Respiratory quotient (RQ)
Time frame: Weeks 0 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 12835281Kipnis 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.
- Background: PubMed 12835280Subar 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.
- Background: PubMed 1877501Tarasuk 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.
- Derived from this study: PubMed 41047130Johnson 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.
- Derived from this study: PubMed 36095134Mitchell 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.
- Derived from this study: PubMed 35511610Johnson 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.
- Derived from this study: PubMed 33938613Mitchell 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.
- Derived from this study: PubMed 33676366Johnson 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.
- Derived from this study: PubMed 31515553Votruba 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.
- Derived from this study: PubMed 30651576Stinson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Votruba, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1. Meat, no fish or soda, 2. Meat and soda, no fish and 3. Meat and fish, no soda in people with Diet Therapy and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIR (time frame: Weeks 0, 2, 4, 6, 8, 10, 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237093, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.