Ultra-Processed Foods, Palatability, Appetite, and Gastrointestinal Transit
2026年5月20日 更新者：Richard Mattes、Purdue University
Ultra-Processed Foods - Palatability and Appetite
The goal of this clinical trial is to learn how food processing level affects appetite and gastrointestinal transit time when meal palatability is changed.
Participants will complete one screening visit and four test visits.
During each test visit, participants will consume one of four meals that differ by food processing level and palatability: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, or low-palatability non-ultra-processed food.
The main questions this study aims to answer are whether food processing and palatability affect appetite sensations and gastrointestinal transit time.
Participants will rate appetite sensations during each test visit and provide breath samples to measure gastrointestinal transit time.
調査の概要
状態
完了
詳細な説明
This is a randomized crossover trial examining the effects of food processing level and palatability on appetite and gastrointestinal transit time.
Participants will complete a screening visit followed by four test visits, with each test visit separated by at least one week.
Each participant will consume all four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food.
Palatability will be reduced by adding bitter melon powder to the low-palatability meals.
During each test visit, participants will consume the assigned test meal containing lactulose as a marker of gastrointestinal transit time.
Breath samples will be collected to assess orocecal transit time using hydrogen analysis.
Participants will also rate meal palatability and appetite sensations, including hunger, fullness, desire to eat, amount they could eat, and thirst, using visual analog scales during the test visit.
研究の種類
介入
入学 (実際)
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。
研究場所
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Indiana
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West Lafayette、Indiana、アメリカ、47907
- Purdue University
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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
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Individuals aged 18 to 60 years.
- Any sex, gender, or orientation.
- Self-reported good health.
- No medication use.
- No allergies or food sensitivities to any of the foods used in the study.
- No anticipated change in physical activity during the study period.
- Willingness to complete all planned study activities, including the screening visit and four test visits.
- At screening, participants must rate the selected high-palatability foods between 60 and 90 on a 100-unit visual analog scale, where 100 = extremely palatable.
- At screening, participants must rate the selected low-palatability foods between 10 and 40 on a 100-unit visual analog scale.
Exclusion Criteria:
- Younger than 18 years or older than 60 years.
- Current medication use.
- Allergies or food sensitivities to any study foods.
- Not meeting the required palatability rating ranges during screening.
- Anticipated change in physical activity during the study period.
- Not self-reporting good health.
- Unwillingness or inability to complete the planned study activities.
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：基礎科学
- 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 |
|---|---|
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実験的：Palatable Ultra-Processed Food
Participants will consume a palatable ultra-processed test meal during one study visit.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
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Participants will consume a palatable ultra-processed test meal during one study visit.
The meal will consist of commonly available ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
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実験的：Unpalatable Ultra-Processed Food
Participants will consume an unpalatable ultra-processed test meal during one study visit.
Palatability will be reduced by adding bitter melon powder.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
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Participants will consume an unpalatable ultra-processed test meal during one study visit.
Palatability will be reduced by adding organic bitter melon powder to the ultra-processed meal.
The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
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実験的：Palatable Non-Ultra-Processed Food
Participants will consume a palatable non-ultra-processed test meal during one study visit.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
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Participants will consume a palatable non-ultra-processed test meal during one study visit.
The meal will consist of commonly available non-ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
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実験的：Unpalatable Non-Ultra-Processed Food
Participants will consume a unpalatable non-ultra-processed test meal during one study visit.
Palatability will be reduced by adding bitter melon powder.
The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time.
|
Participants will consume an unpalatable non-ultra-processed test meal during one study visit.
Palatability will be reduced by adding organic bitter melon powder to the non-ultra-processed meal.
The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
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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 |
|---|---|---|
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Orocecal Transit Time
時間枠：During each test visit, up to 4.5 hours after meal consumption
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Orocecal transit time will be assessed using hydrogen analysis of end-alveolar breath samples collected after consumption of each test meal.
Each test meal will contain lactulose as a marker of gastrointestinal transit time.
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During each test visit, up to 4.5 hours after meal consumption
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Appetite Sensations
時間枠：During each test visit, up to 4.5 hours after meal consumption
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Appetite sensations, including hunger, fullness, desire to eat, prospective food consumption, and thirst, will be assessed using 100-mm visual analog scales during each test visit after consumption of the assigned test meal every 30 minutes.
Each visual analog scale ranges from 0 to 100 mm, with higher scores indicating a greater intensity of the rated sensation.
Higher scores are not inherently better or worse outcomes, but reflect greater hunger, fullness, desire to eat, prospective food consumption, or thirst, depending on the item.
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During each test visit, up to 4.5 hours after meal consumption
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Meal Palatability Ratings
時間枠：During each test visit, up to 4.5 hours after meal consumption
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Meal palatability will be assessed using a 100-mm general labeled magnitude scale during each study visit.
The scale ranges from 0 to 100 mm, with 0 mm anchored by "most disliked sensation imaginable," 50 mm anchored by "neutral," and 100 mm anchored by "most liked sensation imaginable."
Higher scores indicate greater liking of the test meal and therefore a more favorable palatability rating.
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During each test visit, up to 4.5 hours after meal consumption
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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。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (実際)
2024年9月24日
一次修了 (実際)
2026年4月30日
研究の完了 (実際)
2026年4月30日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月20日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRB-2024-450
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?
いいえ
IPD プランの説明
Individual participant data will not be shared because the current IRB-approved protocol does not include a formal plan for external individual participant data sharing.
Study data will be de-identified for analysis, and identifying information will be stored separately from study data.
Code numbers linking participants to their data will be destroyed according to the approved protocol.
No information by which participants can be identified will be released or published.
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。
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