Ultra-Processed Foods, Palatability, Appetite, and Gastrointestinal Transit
2026년 5월 20일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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West Lafayette, Indiana, 미국, 47907
- Purdue University
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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
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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.
|
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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Orocecal Transit Time
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2024년 9월 24일
기본 완료 (실제)
2026년 4월 30일
연구 완료 (실제)
2026년 4월 30일
연구 등록 날짜
최초 제출
2026년 5월 14일
QC 기준을 충족하는 최초 제출
2026년 5월 14일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 20일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IRB-2024-450
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
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. .
식습관에 대한 임상 시험
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Western University, Canada아직 모집하지 않음
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University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘
Palatable Ultra-Processed Food Meal에 대한 임상 시험
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Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한