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Metabolomics-Driven Insights Into Ultra-Processed Foods

16. juli 2026 oppdatert av: Deirdre K Tobias, ScD, Brigham and Women's Hospital

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?

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hopital Center for Clinical Investigation
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.
Eksperimentell: Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.
Eksperimentell: Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.
Eksperimentell: Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.
Eksperimentell: Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.
Eksperimentell: Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
Annen: UPF Test Diet A: Starchy, refined grains
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.
Annen: UPF Test Diet B: Meat, fish, and bread products
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.
Annen: UPF Diet C: Dairy products, including cheese and cream
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
Tidsramme: 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.
Day 0, Day 7, and Day 14 of each dietary intervention period

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brigham and Women's Hospital

Samarbeidspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Broad Institute of MIT and Harvard

Etterforskere

  • Hovedetterforsker: Deirdre K Tobias, ScD, Brigham and Women's Hospital
  • Hovedetterforsker: Shilpa Bhupathiraju, PhD, Brigham and Women's Hospital
  • Hovedetterforsker: Frank B Hu, MD PhD, Harvard School of Public Health (HSPH)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

16. juli 2026

Først innsendt som oppfylte QC-kriteriene

16. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026P001870
  • 1R01DK145733-01A1 (Annet stipend/finansieringsnummer: NIH (Pending))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 1 year after publication with no end date.

Tilgangskriterier for IPD-deling

A Controlled Access Repository: Requests for data are reviewed by an access committee per established policies and procedures; providers may establish data use restrictions; the access period is limited; a data user's institution must sign a DUA that is similar to an NIH DUC or FDP DTUA template; data users may need to produce a data security plan.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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