Metabolomics-Driven Insights Into Ultra-Processed Foods
2026年7月16日 更新者：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
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Deirdre K Tobias, ScD
- 電話番号：617-278-0844
- メール：dtobias@bwh.harvard.edu
研究場所
-
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hopital Center for Clinical Investigation
-
コンタクト：
- Yemi Talabi-Oates, MBA
- 電話番号：617-732-8750
- メール：cci@bwh.harvard.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Deirdre K Tobias, ScD、Brigham and Women's Hospital
- 主任研究者：Shilpa Bhupathiraju, PhD、Brigham and Women's Hospital
- 主任研究者：Frank B Hu, MD PhD、Harvard School of Public Health (HSPH)
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2028年3月1日
研究の完了 (推定)
2028年3月1日
試験登録日
最初に提出
2026年7月16日
QC基準を満たした最初の提出物
2026年7月16日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月16日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026P001870
- 1R01DK145733-01A1 (その他の助成金/資金番号：NIH (Pending))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 1 year after publication with no end date.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。