Testing the Abuse Liability of Hyper-palatable Foods
2026년 9월 11일 업데이트: University of Kansas
Bet You Can't Eat Just One: Testing the Abuse Liability of Hyper-palatable Foods
The study will conduct a laboratory study designed to evaluate the rewarding and addictive properties of hyper-palatable foods (HPF), using potato chips as the food stimulus/sample HPF.
연구 개요
상태
모병
상세 설명
A within-subjects, double-blind, randomized crossover design will be used to test the abuse liability of a commonly consumed hyper-palatable food (HPF; potato chips) in controlled laboratory conditions, compared to a negative (non-HPF) control and modified doses (Aim 1).
In alignment with FDA requirements, the study will randomize participants to complete four study sessions in one of four mixed orders to counterbalance the ordering of food stimuli across participants.
One food will be assessed per session.
Abuse liability tests will consist of an acute dose effects comparison to evaluate differences in acute rewarding effects, and a test of HPF reinforcing effects via a self-administration task and behavioral economic food purchase task.
Participants will be community members who report high dietary intake of potato chips (HPF stimulus in the study), and do not have substance use disorder or eating disorders, which may present confounds.
연구 유형
중재적
등록 (추정된)
168
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Tera Fazzino, Doctorate
- 전화번호: 785-864-0062
- 이메일: tfazzino@ku.edu
연구 연락처 백업
- 이름: Cash Petree, B.S.
- 전화번호: 615-999-5677
- 이메일: cashpetree@ku.edu
연구 장소
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Kansas
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Lawrence, Kansas, 미국, 66049
- 모병
- Dole Human Development Center
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연락하다:
- Tera Fazzino, Doctorate
- 전화번호: 785-864-0062
- 이메일: tfazzino@ku.edu
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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
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Adults 18+ years old
- High dietary intake of regular potato chips (HPF stimulus in the study), identified as >=3 times per week via a standard dietary history questionnaire
- Like potato chips, the study-provided food (rating of >6 out of 10 on visual analogue scale) and willing to consume them in the lab.
Exclusion Criteria:
- Currently prescribed medications for weight loss (e.g., Ozempic), attention deficit hyperactivity disorder, substance use disorder, or binge eating disorder
- Substance use disorder diagnosis in the past year (self-reported) or substantial consequences from substance use in the past year (score on Drug Abuse Screening Test-10 of 6 or higher)
- Eating disorder diagnosis in the past year
- Bariatric surgery in the past year
- Dietary allergies or restrictions to gluten
- Dietary allergies or restrictions to root vegetables
- Currently participating in a weight management treatment program or engaging in dietary modification to induce weight loss
- Trying to cut down on HPF intake
- Diagnosed smell or taste dysfunction
- Currently pregnant
- Diagnosed cognitive impairment (self-reported)
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Sequence 1: Full Dose HPF → Modified Dose- No Fat → Modified Dose No Sodium → Negative Control
Participants receive Full Dose HPF chip at Visit 1, Modified Dose- No Fat chip at Visit 2, Modified Dose- No Sodium chip at Visit 3, and Negative Control chip at Visit 4.
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This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
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다른: Sequence 2: Modified Dose- No Fat → Modified Dose- No Sodium → Negative Control → Full Dose HPF
Participants receive Modified Dose- No Fat chip at Visit 1, Modified Dose- No Sodium chip at Visit 2, Negative Control chip at Visit 3, and Full Dose HPF chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
|
|
다른: Sequence 3: Modified Dose- No Sodium → Negative Control → Full Dose HPF → Modified Dose- No Fat
Participants receive Modified No Salt chip at Visit 1, Negative Control chip at Visit 2, Full Dose HPF chip at Visit 3, and Modified No Fat chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
|
|
다른: Sequence 4: Negative Control → Full Dose HPF → Modified Dose- No Fat → Modified Dose- No Sodium
Participants receive Negative Control chip at Visit 1, Full Dose HPF chip at Visit 2, Modified No Fat chip at Visit 3, and Modified No Salt chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective effect measure: food stimulus liking
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they like the food stimulus they tasted
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Baseline, at each visit
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Subjective effect measure: food stimulus wanting/desire
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they desire more of the food stimulus they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus craving
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they crave the food stimulus they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus likelihood to use again
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how likely they would be to use the food stimulus they tasted again in the future.
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Baseline, at each visit
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Demand elasticity value of the food stimulus
기간: Baseline, at each visit
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Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price.
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Baseline, at each visit
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Breakpoint value in self-administration task
기간: Baseline, at each visit
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Highest schedule completed to earn a food stimulus reward during the self-administration task
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Baseline, at each visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective effect measure: food stimulus flavor intensity
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how intense the flavor of the food stimulus is that they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus relaxation
기간: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how relaxed they felt from the food stimulus they tasted.
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Baseline, at each visit
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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)
2026년 9월 8일
기본 완료 (추정된)
2030년 11월 1일
연구 완료 (추정된)
2031년 1월 30일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 8월 17일
처음 게시됨 (실제)
2026년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00151790
- 1R01DA062585-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Participant-level data will be shared with National Addiction & Health Data Archive Program (NAHDAP).
IPD 공유 기간
When the main outcomes are published (anticipated 2031)
IPD 공유 액세스 기준
Study data will be housed at NIH's National Data Archive.
Other study details will be posted on the study's clinicaltrials.gov
site.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
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. .