Metabolomics-Driven Insights Into Ultra-Processed Foods
2026년 7월 16일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Deirdre K Tobias, ScD
- 전화번호: 617-278-0844
- 이메일: dtobias@bwh.harvard.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hopital Center for Clinical Investigation
-
연락하다:
- Yemi Talabi-Oates, MBA
- 전화번호: 617-732-8750
- 이메일: cci@bwh.harvard.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Sequence 1
Participants receive Diet A, followed by Diet B, followed by Diet C.
|
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.
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.
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.
|
|
실험적: Sequence 2
Participants receive Diet A, followed by Diet C, followed by Diet B.
|
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.
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.
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.
|
|
실험적: Sequence 3
Participants receive Diet B, followed by Diet A, followed by Diet C.
|
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.
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.
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.
|
|
실험적: Sequence 4
Participants receive Diet B, followed by Diet C, followed by Diet A.
|
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.
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.
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.
|
|
실험적: Sequence 5
Participants receive Diet C, followed by Diet A, followed by Diet B.
|
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.
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.
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.
|
|
실험적: Sequence 6
Participants receive Diet C, followed by Diet B, followed by Diet A.
|
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.
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.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Deirdre K Tobias, ScD, Brigham and Women's Hospital
- 수석 연구원: Shilpa Bhupathiraju, PhD, Brigham and Women's Hospital
- 수석 연구원: Frank B Hu, MD PhD, Harvard School of Public Health (HSPH)
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 1일
기본 완료 (추정된)
2028년 3월 1일
연구 완료 (추정된)
2028년 3월 1일
연구 등록 날짜
최초 제출
2026년 7월 16일
QC 기준을 충족하는 최초 제출
2026년 7월 16일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 16일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026P001870
- 1R01DK145733-01A1 (기타 보조금/기금 번호: NIH (Pending))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Beginning 1 year after publication with no end date.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .