Biological MarkersNCT05616585
Dietary Biomarkers Intervention Core
A study of Biological Markers and Diet, Healthy, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies. This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biological Markers, Diet, Healthy, Metabolomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Oct 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults Men and women, 18+
- Body Mass Index (BMI) 18.5-39.9 kg/m2
- Willingness to participate in all study visits
Who cannot join
- History of gastrointestinal conditions (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)
- Bleeding disorders that preclude blood draws
- Anemia- as self-reported in the Screening Questionnaire
- Previous gastrointestinal resection or gastric bypass surgery
- Recent hospital admissions (in past 6 months) for heart disease (myocardial infarction, cerebrovascular accident, or congestive heart failure) or other cerebrovascular/ coronary artery disease condition under physician guided therapy that is not medically stable.
- Cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment. Except for non-melanoma skin cancer.
Show all 48Show fewer
- Women who are pregnant or lactating
- Weight change (±5% in3 months)
- Regular alcohol intake of >2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits) and unwilling to abstain during feeding periods
- Use of tobacco, marijuana, hookahs, vape, or e-cigarettes and not willing to abstain during feeding periods.
- Use of illicit drugs and not willing abstain during feeding periods.
- Body mass index >40 kg/m2
- Hypertension- seated blood pressure >140 mmHg or diastolic >90 mmHg
- Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.
- Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and unwilling to stop taking these during feeding periods
- Unwilling to stop taking over the counter dietary supplements that interfere with the test foods being studied, including pills, chewable, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (incl. cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine, and chondroitin. If vitamin supplement is MD prescribed, the participant may be enrolled subject to the investigator's judgment. Staff will review supplement to determine eligibility.
- Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)
- Inability to freely give informed consent
- Clinical lab tests outside acceptable value as ascertained at a screening blood draw and current use of specific prescription medications per self-report
- Description [Acceptable Values]
- Glucose-Fasting: Serum Glucose [54-125 mg/dl]
- Blood Urea Nitrogen [6-50mg/dl]
- Serum Creatinine [0.4-1.3 mg/dl]
- Estimated glomerular filtration rate (eGFR) [>60ml/min]
- Serum Sodium [133-146 mmol/L]
- Alanine Aminotransferase/glutamate-pyruvate transaminase (ALT/GPT) Liver Enzyme [5-60 U/L]
- Aspartate aminotransferase (AST/GOT) Liver Enzyme [5-40 U/L]
- Alkaline Phosphatase Liver Enzyme [20-135 U/L]
- Total Bilirubin Liver Function [0.0-1.9 mg/dl]
- Total Serum Protein [5-9.0 g/dl]
- Albumin Serum Protein [3.5-5.9 g/dl]
- LDL Cholesterol [<160 mg/dl]
- Triglycerides [<500 mg/dl]
- White Blood Cells (WBC) [3-10.5 K/per microliter (μL)]
- Hematocrit (HCT) (women) [35-48 g/dl]
- Hematocrit (HCT) (men) [37.5-49 g/dl]
- Prescription Medications that would Exclude Participation:
- Diuretics
- Steroids (oral): daily oral any dose within 1 month of study, except as noted below
- Nonsteroidal anti-inflammatory drugs (NSAIDS): when prescribed for treatment or is regularly consumed (i.e.. Daily), or can't be stopped for 2 days without pain, except 81 mg Aspirin
- Opiates: any use within 1 month of study
- Antilipemic Agents that affect GI or renal function (i.e.. Fibrates)
- Antidiabetics and Hypoglycemic medications other than metformin (i.e.. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
- Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)
- Biologics/immune modulators (i.e.. rheumatoid arthritis (RA), psoriasis, other rheumatologic/hematologic active disease)
- Anti-coagulants (coumadin, heparin, Eliquis, etc.)
- Human immunodeficiency virus (HIV) or highly active antiretroviral therapy (HAART) , etc.
- Medications that are approved: Steroids (nasal or topical), Aspirin, NSAIDS and Tylenol (avoid day before and day of study visit, Statins, Metformin, Psychiatric drugs other than anti-psychotics (SSRI, tricyclics, benzo), oral contraception pill (OCP)/Hormonal Replacement Therapy (HRT), Tobacco cessation products (patches/lozenge), Oral contraceptives, Gender- affirming HRT, Testosterone for hypogonadal males.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mass General Brigham Center for Clinical Investigation
Boston, Massachusetts, 02115
About this study
Official title: Dietary Biomarkers Development Center at Harvard University: Intervention Core
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies.
This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial.
- In the PK study, eight foods will be tested, each on a single day, and the design is crossover.
- In the DR, the effects of 10 foods will be compared to each other in a randomized, parallel-group design, and the dose-effect of each of the 10 foods will be determined in a randomized, crossover design.
Read the detailed description
Diet is one of the most important determinants of human health and an essential component of population-wide primary prevention strategies. However, there is controversy about the quality and reliability of population- based nutrition research. The vast majority of evidence for healthy eating is informed by large studies with dietary patterns assessed via self-report. Self-reported tools have well-recognized limitations. Plasma biomarkers have been a mainstay of epidemiologic studies. Recent advances in metabolomics technology have similarly fostered discovery of metabolites that are highly specific to intakes of foods or food groups. Metabolomics offers a tangible opportunity to identify novel metabolomic signatures for a range of foods and nutrients. However, this progress relies on the tremendous need for controlled feeding studies to identify and validate metabolites specific to each food item and group.
This research will identify objective biomarkers of dietary intake that can serve as independent markers of dietary intake and complement current dietary intake assessment methods. The knowledge gained in this approach will thus address a critical gap with immediate benefits to the larger nutrition research community, both in observational and clinical trial settings, to improve the validity of major public health research initiatives. The Intervention Core, will perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies across a range of food items and food groups in diverse populations. The investigators will focus on common foods from the protein, carbohydrates, and dairy food groups: (1) chicken, beef, salmon, and soybeans;(2) yogurt, cheese; and (3) whole wheat bread, potatoes, corn, and oats.
Pharmacokinetic (PK): Each participant will complete a sequence of dietary intakes of up to 8 test foods in a randomized, crossover study, blinded according to the order of randomization. In each of the eight feeding cycles a control diet is provided for a 2 day run-in, after which each participant will be given a pre-specified amount of the test foods, i.e., beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, or oats. Blood and urine samples will be taken at time zero, every hour for blood or two hours for urine after eating, over 10 hours, and at 24 hours for untargeted Liquid chromatography-mass spectrometry (LC-MS) metabolomic analysis.
Dose Response (DR):The DR study is an isocaloric, controlled feeding study that will examine three dose levels for 10 foods in five pairings. A total of 100 eligible adults (20 per food group pairing) (will be assigned to beef/potatoes, chicken/whole wheat bread, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for six days each in a randomized crossover design.
- Conditions
- Biological Markers, Diet, Healthy, Metabolomics, Nutrition, Healthy
- Being tested
- Pharmacokinetic (PK)- Controlled Feeding Diet, Dose Response (DR)- Controlled Feeding Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic (PK)- Controlled Feeding DietOther
Pharmacokinetic- single-day isocaloric meals of beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, and oats with blood and urine samples taken at Time Zero and every hour (blood) or two hours (urine) after eating, over 10 hours; and at 24 hr.
Dose Response (DR)- Controlled Feeding DietOther
Dose Response-3 level, six days controlled feeding study with assignment to either beef/whole wheat bread, chicken/potato, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for 6 days.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Experimental | Single Day Intervention of 10 test foods Receives: Other: Pharmacokinetic (PK)- Controlled Feeding Diet |
| Dose Response | Experimental | Six day, 3 level (zero, medium, high dose) controlled feeding study Receives: Other: Dose Response (DR)- Controlled Feeding Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Urine samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies.
A number of biomarkers will be identified for the test foods. These biomarkers will be measured using liquid chromatography-mass spectrometry (LC/MS) and nuclear magnetic resonance (NMR) spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids, and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
Measured: Pharmacokinetic Phase1: [Time Frame: 0, 2, 4, 6, 8, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days controlled feeding of paired test foods.
Serum/plasma biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Blood samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies.
A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
Measured: Pharmacokinetic Phase 1 [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.
Stool biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
. Stool samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies.
A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
Measured: Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Feb 2023
- Primary completion31 Aug 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological MarkersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Sacks, Harvard School of Public Health (HSPH)
- Investigators
- Frank M Sacks, MD, Principal investigator, Harvard School of Public Health (HSPH)Jonathan S Williams, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616585
- Sponsor's protocol ID
- IRB21-1067
- Other IDs
- 1U2CDK129670-01
- Status last verified
- Oct 2025
- First submitted
- 28 Oct 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, Mishchuk DO, Bain JR, He X, Sun J, Harnly J, Simmons W, Raftery D, Liang L, Newman JW, Fiehn O, Clish CB, Lampe JW, Bennett BJ, Navarro SL, Wang Y, Zheng C, Mossavar-Rahmani Y, McCullough ML, Huang Y, Shojaie A, Zhu W, Djukovic D, Sacks F, Williams J, Steinberg FM, Adams SH, Hu FB, Neuhouser ML, Slupsky CM, Maruvada P. The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition. Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.
PubMed 40641655
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Biomarkers Development Center at Harvard University: Intervention Core
- ClinicalTrials.gov ID
- NCT05616585
- Acronym / sponsor ID
- IRB21-1067
- Conditions
- Biological Markers, Diet, Healthy, Metabolomics, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 15 Nov 2022 (actual)
- 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.
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies.
This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial.
- In the PK study, eight foods will be tested, each on a single day, and the design is crossover.
- In the DR, the effects of 10 foods will be compared to each other in a randomized, parallel-group design, and the dose-effect of each of the 10 foods will be determined in a randomized, crossover design.
Detailed description
Diet is one of the most important determinants of human health and an essential component of population-wide primary prevention strategies. However, there is controversy about the quality and reliability of population- based nutrition research. The vast majority of evidence for healthy eating is informed by large studies with dietary patterns assessed via self-report. Self-reported tools have well-recognized limitations. Plasma biomarkers have been a mainstay of epidemiologic studies. Recent advances in metabolomics technology have similarly fostered discovery of metabolites that are highly specific to intakes of foods or food groups. Metabolomics offers a tangible opportunity to identify novel metabolomic signatures for a range of foods and nutrients. However, this progress relies on the tremendous need for controlled feeding studies to identify and validate metabolites specific to each food item and group.
This research will identify objective biomarkers of dietary intake that can serve as independent markers of dietary intake and complement current dietary intake assessment methods. The knowledge gained in this approach will thus address a critical gap with immediate benefits to the larger nutrition research community, both in observational and clinical trial settings, to improve the validity of major public health research initiatives. The Intervention Core, will perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies across a range of food items and food groups in diverse populations. The investigators will focus on common foods from the protein, carbohydrates, and dairy food groups: (1) chicken, beef, salmon, and soybeans;(2) yogurt, cheese; and (3) whole wheat bread, potatoes, corn, and oats.
Pharmacokinetic (PK): Each participant will complete a sequence of dietary intakes of up to 8 test foods in a randomized, crossover study, blinded according to the order of randomization. In each of the eight feeding cycles a control diet is provided for a 2 day run-in, after which each participant will be given a pre-specified amount of the test foods, i.e., beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, or oats. Blood and urine samples will be taken at time zero, every hour for blood or two hours for urine after eating, over 10 hours, and at 24 hours for untargeted Liquid chromatography-mass spectrometry (LC-MS) metabolomic analysis.
Dose Response (DR):The DR study is an isocaloric, controlled feeding study that will examine three dose levels for 10 foods in five pairings. A total of 100 eligible adults (20 per food group pairing) (will be assigned to beef/potatoes, chicken/whole wheat bread, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for six days each in a randomized crossover design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Experimental | Other: Pharmacokinetic (PK)- Controlled Feeding DietSingle Day Intervention of 10 test foods |
| Dose Response | Experimental | Other: Dose Response (DR)- Controlled Feeding DietSix day, 3 level (zero, medium, high dose) controlled feeding study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults Men and women, 18+
- Body Mass Index (BMI) 18.5-39.9 kg/m2
- Willingness to participate in all study visits
Key exclusion criteria (48 listed)
- History of gastrointestinal conditions (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)
- Bleeding disorders that preclude blood draws
- Anemia- as self-reported in the Screening Questionnaire
- Previous gastrointestinal resection or gastric bypass surgery
- Recent hospital admissions (in past 6 months) for heart disease (myocardial infarction, cerebrovascular accident, or congestive heart failure) or other cerebrovascular/ coronary artery disease condition under physician guided therapy that is not medically stable.
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 |
|---|---|---|
| Pharmacokinetic (PK)- Controlled Feeding DietPharmacokinetic- single-day isocaloric meals of beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, and oats with blood and urine samples taken at Time Zero and every hour (blood) or two hours (urine) after eating, over 10 hours; and at 24 hr. | Other | Pharmacokinetic |
| Dose Response (DR)- Controlled Feeding DietDose Response-3 level, six days controlled feeding study with assignment to either beef/whole wheat bread, chicken/potato, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for 6 days. | Other | Dose Response |
Primary outcome
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Time frame: Pharmacokinetic Phase1: [Time Frame: 0, 2, 4, 6, 8, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days controlled feeding of paired test foods.
Urine samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies. A number of biomarkers will be identified for the test foods. These biomarkers will be measured using liquid chromatography-mass spectrometry (LC/MS) and nuclear magnetic resonance (NMR) spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids, and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
Serum/plasma biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Time frame: Pharmacokinetic Phase 1 [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.
Blood samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies. A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
Stool biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Time frame: Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.
. Stool samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies. A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.
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 7 Oct 2025.
- Derived from this study: PubMed 40641655Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, Mishchuk DO, Bain JR, He X, Sun J, Harnly J, Simmons W, Raftery D, Liang L, Newman JW, Fiehn O, Clish CB, Lampe JW, Bennett BJ, Navarro SL, Wang Y, Zheng C, Mossavar-Rahmani Y, McCullough ML, Huang Y, Shojaie A, Zhu W, Djukovic D, Sacks F, Williams J, Steinberg FM, Adams SH, Hu FB, Neuhouser ML, Slupsky CM, Maruvada P. The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition. Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.
- Biomarkers Consortium WebsiteLink provided by the sponsor.
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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.
Frank M Sacks, MD principal investigator
Harvard School of Public Health (HSPH)
Jonathan S Williams, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Biological Markers and Diet, Healthy, run by Harvard School of Public Health (HSPH) 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 48 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 7 Oct 2025. 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.
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?
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples. (time frame: Pharmacokinetic Phase1: [Time Frame: 0, 2, 4, 6, 8, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days controlled feeding of paired test foods.). The study lists 3 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 NCT05616585, which also lists 1 linked publication.
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 7 Oct 2025.