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Metabolomics-Driven Insights Into Ultra-Processed Foods

16 июля 2026 г. обновлено: 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

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

40

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Deirdre K Tobias, ScD
  • Номер телефона: 617-278-0844
  • Электронная почта: dtobias@bwh.harvard.edu

Места учебы

  • Соединенные Штаты
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02115
        • Brigham and Women's Hopital Center for Clinical Investigation
        • Контакт:
          • Yemi Talabi-Oates, MBA
          • Номер телефона: 617-732-8750
          • Электронная почта: cci@bwh.harvard.edu

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
Другой: 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.
Другой: 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.
Другой: 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.
Экспериментальный: Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
Другой: 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.
Другой: 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.
Другой: 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.
Экспериментальный: Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
Другой: 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.
Другой: 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.
Другой: 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.
Экспериментальный: Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
Другой: 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.
Другой: 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.
Другой: 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.
Экспериментальный: Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
Другой: 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.
Другой: 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.
Другой: 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.
Экспериментальный: Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
Другой: 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.
Другой: 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.
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Brigham and Women's Hospital

Соавторы

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

Следователи

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 января 2027 г.

Первичное завершение (Оцененный)

1 марта 2028 г.

Завершение исследования (Оцененный)

1 марта 2028 г.

Даты регистрации исследования

Первый отправленный

16 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

16 июля 2026 г.

Первый опубликованный (Действительный)

21 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 2026P001870
  • 1R01DK145733-01A1 (Другой номер гранта/финансирования: NIH (Pending))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Сроки обмена IPD

Beginning 1 year after publication with no end date.

Критерии совместного доступа к IPD

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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • АНАЛИТИЧЕСКИЙ_КОД
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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