Diet, Food and NutritionNCT07717970
Metabolomics-Driven Insights Into Ultra-Processed Foods
A study testing UPF Test Diet A: Starchy, refined grains, UPF Test Diet B: Meat, fish, and bread products and UPF Diet C: Dairy products, including cheese and cream in people with Diet, Food and Nutrition, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this dietary intervention study in generally healthy adults is to develop new ways to use blood samples to measure the common types of highly processed foods and beverages that people eat on a regular basis. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Food and Nutrition
- What is being tested?
- UPF Test Diet A: Starchy, refined grains, UPF Test Diet B: Meat, fish, and bread products and UPF Diet C: Dairy products, including cheese and cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, ages 20 to 65 years.
- BMI 18.5 to 39.9 kg/m2.
- No known food allergies, intolerances, or sensitivities (e.g., gluten, dairy, monosodium-glutamate).
- Not following a restrictive diet for health, religious, or other reasons (e.g., vegetarian, vegan).
- Willingness to participate and give informed consent.
- Willingness to consume dietary intervention foods and beverages.
Who cannot join
- BMI <18.5 or >39.9 kg/m2.
- Pregnant, lactating, or planning on becoming pregnant in the next 6 months.
- History of bariatric surgery.
- Currently taking medications impacting appetite or body weight.
- History of major chronic diseases, including cardiovascular disease, type 1 or 2 diabetes, major gastrointestinal conditions, uncontrolled hypertension (seated blood pressure systolic >140 mmHg or diastolic >90 mmHg), history of invasive cancer, current use of immunosuppressants, and other major chronic diseases and conditions affecting participation, adherence, or study endpoints.
- Unwilling or unable to comply with all in person scheduled visits, dietary protocols, study protocol, and other study procedures.
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- Food allergies or aversions to the foods provided in the dietary interventions.
- Non-English speaking.
- Other members of the same household are already participating in the research study.
- Planning on moving out of the Boston area in the next 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hopital Center for Clinical Investigation
Boston, Massachusetts, 02115
Yemi Talabi-Oates, MBA, 617-732-8750, cci@bwh.harvard.edu
About this study
Official title: Metabolomics-Driven Insights Into Ultra-Processed Foods: Identifying High-Risk UPF Subtypes for T2D Prevention
The goal of this dietary intervention study in generally healthy adults is to develop new ways to use blood samples to measure the common types of highly processed foods and beverages that people eat on a regular basis. The main aims to answer are:
What small molecules are elevated in blood after eating different types of highly processed foods and beverages consistently for 1 week?
Read more
Researchers will compare 3 different test diets with 1 control diet that does not have any highly processed foods in the same individuals to see which circulating blood markers change.
Participants will:
- Complete 3 diet phases, each 2 weeks long
- Receive a meal plan and study foods and beverages to follow for each 2-week phase
- Come to the clinic every week for blood draws, urine samples, and stool collection kits
Read the detailed description
UPFs, characterized by industrial processing and the use of cosmetic additives for enhanced palatability and extended shelf-life, account for approximately 58% of caloric intake in the U.S. population. Although some UPF subtypes have been implicated in increasing risk of T2D and other chronic diseases, others may be relatively inert or even beneficial, underscoring the need for discerning their distinct health effects. This trial is a controlled crossover feeding trial design with target enrollment of 40 generally healthy adults. Partcipants complete 3 2-week isocaloric dietary intervention phases, with 1 week of a control diet of non-ultraprocessed foods and beverages, and 1 week of a UPF-based test diet. The 3 UPF test diets each feature a menu consisting of a UPF subtype: starchy and refined grains, meats and fish, or dairy-based products. Foods and beverages are provided during the diet phases, and participants will attend weekly clinic visits for in-person assessments and biospecimen collections. We will obtain metabolomic profiling of the fasting plasma samples and conduct data analyses to isolate novel biomarkers that reflect the intake of the UPFs, such as industrial additives. These objective signatures of UPF intake will support subsequent research investigating the long-term health outcomes relate d to UPF consumption. Identifying metabolomic signatures of UPF subtypes will enhance the understanding of the biological mechanisms linking UPFs to T2D and other chronic disease risks.
- Conditions
- Diet, Food and Nutrition
- Being tested
- UPF Test Diet A: Starchy, refined grains, UPF Test Diet B: Meat, fish, and bread products, UPF Diet C: Dairy products, including cheese and cream
- Keywords
- feeding trial, dietary intervention, ultra-processed foods, metabolomics, crossover trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPF Test Diet A: Starchy, refined grainsOther
The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consistently of starchy foods and refined grain products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.
UPF Test Diet B: Meat, fish, and bread productsOther
The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consisting of meat, fish, and bread products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.
UPF Diet C: Dairy products, including cheese and creamOther
The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consisting of dairy products, including cheese and cream. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants receive Diet A, followed by Diet B, followed by Diet C. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
| Sequence 2 | Experimental | Participants receive Diet A, followed by Diet C, followed by Diet B. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
| Sequence 3 | Experimental | Participants receive Diet B, followed by Diet A, followed by Diet C. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
| Sequence 4 | Experimental | Participants receive Diet B, followed by Diet C, followed by Diet A. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
| Sequence 5 | Experimental | Participants receive Diet C, followed by Diet A, followed by Diet B. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
| Sequence 6 | Experimental | Participants receive Diet C, followed by Diet B, followed by Diet A. Receives: Other: UPF Test Diet A: Starchy, refined grains; Other: UPF Test Diet B: Meat, fish, and bread products; Other: UPF Diet C: Dairy products, including cheese and cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
The primary outcome for this study is within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. Metabolomic responses will be quantified from metabolite concentrations (e.g., relative abundance) measured in fasting plasma samples collected at day 0, day 7, and day 14 in each diet phase.
Measured: Day 0, Day 7, and Day 14 of each dietary intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Food and NutritionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Broad Institute of MIT and Harvard
- Responsible party
- Principal investigator, Deirdre K Tobias, ScD, Brigham and Women's Hospital
- Investigators
- Deirdre K Tobias, ScD, Principal investigator, Brigham and Women's HospitalShilpa Bhupathiraju, PhD, Principal investigator, Brigham and Women's HospitalFrank B Hu, MD PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717970
- Sponsor's protocol ID
- 2026P001870
- Other IDs
- 1R01DK145733-01A1
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. We will not share any data that include participant identifiers, sensitive or genomic data, or videos, photographs, or audio recordings.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics-Driven Insights Into Ultra-Processed Foods: Identifying High-Risk UPF Subtypes for T2D Prevention
- ClinicalTrials.gov ID
- NCT07717970
- Acronym / sponsor ID
- 2026P001870
- Conditions
- Diet, Food and Nutrition
- Keywords
- feeding trial, dietary intervention, ultra-processed foods, metabolomics, crossover trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Broad Institute of MIT and Harvard
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 21 Jul 2026 (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 goal of this dietary intervention study in generally healthy adults is to develop new ways to use blood samples to measure the common types of highly processed foods and beverages that people eat on a regular basis. The main aims to answer are:
What small molecules are elevated in blood after eating different types of highly processed foods and beverages consistently for 1 week?
Researchers will compare 3 different test diets with 1 control diet that does not have any highly processed foods in the same individuals to see which circulating blood markers change.
Participants will:
- Complete 3 diet phases, each 2 weeks long
- Receive a meal plan and study foods and beverages to follow for each 2-week phase
- Come to the clinic every week for blood draws, urine samples, and stool collection kits
Detailed description
UPFs, characterized by industrial processing and the use of cosmetic additives for enhanced palatability and extended shelf-life, account for approximately 58% of caloric intake in the U.S. population. Although some UPF subtypes have been implicated in increasing risk of T2D and other chronic diseases, others may be relatively inert or even beneficial, underscoring the need for discerning their distinct health effects. This trial is a controlled crossover feeding trial design with target enrollment of 40 generally healthy adults. Partcipants complete 3 2-week isocaloric dietary intervention phases, with 1 week of a control diet of non-ultraprocessed foods and beverages, and 1 week of a UPF-based test diet. The 3 UPF test diets each feature a menu consisting of a UPF subtype: starchy and refined grains, meats and fish, or dairy-based products. Foods and beverages are provided during the diet phases, and participants will attend weekly clinic visits for in-person assessments and biospecimen collections. We will obtain metabolomic profiling of the fasting plasma samples and conduct data analyses to isolate novel biomarkers that reflect the intake of the UPFs, such as industrial additives. These objective signatures of UPF intake will support subsequent research investigating the long-term health outcomes relate d to UPF consumption. Identifying metabolomic signatures of UPF subtypes will enhance the understanding of the biological mechanisms linking UPFs to T2D and other chronic disease risks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet A, followed by Diet B, followed by Diet C. |
| Sequence 2 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet A, followed by Diet C, followed by Diet B. |
| Sequence 3 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet B, followed by Diet A, followed by Diet C. |
| Sequence 4 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet B, followed by Diet C, followed by Diet A. |
| Sequence 5 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet C, followed by Diet A, followed by Diet B. |
| Sequence 6 | Experimental | Other: UPF Test Diet A: Starchy, refined grains, Other: UPF Test Diet B: Meat, fish, and bread products, Other: UPF Diet C: Dairy products, including cheese and creamParticipants receive Diet C, followed by Diet B, followed by Diet A. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults, ages 20 to 65 years.
- BMI 18.5 to 39.9 kg/m2.
- No known food allergies, intolerances, or sensitivities (e.g., gluten, dairy, monosodium-glutamate).
- Not following a restrictive diet for health, religious, or other reasons (e.g., vegetarian, vegan).
- Willingness to participate and give informed consent.
Key exclusion criteria (10 listed)
- BMI <18.5 or >39.9 kg/m2.
- Pregnant, lactating, or planning on becoming pregnant in the next 6 months.
- History of bariatric surgery.
- Currently taking medications impacting appetite or body weight.
- History of major chronic diseases, including cardiovascular disease, type 1 or 2 diabetes, major gastrointestinal conditions, uncontrolled hypertension (seated blood pressure systolic >140 mmHg or diastolic >90 mmHg), history of invasive cancer, current use of immunosuppressants, and other major chronic diseases and conditions affecting participation, adherence, or study endpoints.
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 |
|---|---|---|
| UPF Test Diet A: Starchy, refined grainsThe 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consistently of starchy foods and refined grain products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial. | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| UPF Test Diet B: Meat, fish, and bread productsThe 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consisting of meat, fish, and bread products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial. | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| UPF Diet C: Dairy products, including cheese and creamThe 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with ~60% of calories from UPFs consisting of dairy products, including cheese and cream. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial. | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
Time frame: Day 0, Day 7, and Day 14 of each dietary intervention period
The primary outcome for this study is within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. Metabolomic responses will be quantified from metabolite concentrations (e.g., relative abundance) measured in fasting plasma samples collected at day 0, day 7, and day 14 in each diet phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. We will not share any data that include participant identifiers, sensitive or genomic data, or videos, photographs, or audio recordings.
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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.
Deirdre K Tobias, ScD principal investigator
Brigham and Women's Hospital
Shilpa Bhupathiraju, PhD principal investigator
Brigham and Women's Hospital
Frank B Hu, MD PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPF Test Diet A: Starchy, refined grains, UPF Test Diet B: Meat, fish, and bread products and UPF Diet C: Dairy products, including cheese and cream in people with Diet, Food and Nutrition, run by Brigham and Women's Hospital 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 21 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deirdre K Tobias, ScD (617-278-0844, dtobias@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. (time frame: Day 0, Day 7, and Day 14 of each dietary intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.