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Testing the Abuse Liability of Hyper-palatable Foods

2026年9月11日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

168

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：Tera Fazzino, Doctorate
  • 電話番号：785-864-0062
  • メール：tfazzino@ku.edu

研究連絡先のバックアップ

  • 名前：Cash Petree, B.S.
  • 電話番号：615-999-5677
  • メール：cashpetree@ku.edu

研究場所

  • アメリカ
    • Kansas
      • Lawrence、Kansas、アメリカ、66049
        • 募集
        • Dole Human Development Center
        • コンタクト：
          • Tera Fazzino, Doctorate
          • 電話番号：785-864-0062
          • メール：tfazzino@ku.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 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)

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
他の：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.
他の：Full Dose HPF

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.

他の：Modified Dose- No Fat
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.
他の：Modified Dose- No Sodium
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
他の：Jicama Root Vegetable Chip- Negative Control
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.
他の：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.
他の：Full Dose HPF

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.

他の：Modified Dose- No Fat
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.
他の：Modified Dose- No Sodium
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
他の：Jicama Root Vegetable Chip- Negative Control
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.
他の：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.
他の：Full Dose HPF

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.

他の：Modified Dose- No Fat
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.
他の：Modified Dose- No Sodium
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
他の：Jicama Root Vegetable Chip- Negative Control
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.
他の：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.
他の：Full Dose HPF

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.

他の：Modified Dose- No Fat
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.
他の：Modified Dose- No Sodium
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
他の：Jicama Root Vegetable Chip- Negative Control
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.

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
Subjective effect measure: food stimulus liking
時間枠：Baseline, at each visit
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
Baseline, at each visit
Subjective effect measure: food stimulus wanting/desire
時間枠：Baseline, at each visit
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.
Baseline, at each visit
Subjective effect measure: food stimulus craving
時間枠：Baseline, at each visit
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.
Baseline, at each visit
Subjective effect measure: food stimulus likelihood to use again
時間枠：Baseline, at each visit
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.
Baseline, at each visit
Demand elasticity value of the food stimulus
時間枠：Baseline, at each visit
Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price.
Baseline, at each visit
Breakpoint value in self-administration task
時間枠：Baseline, at each visit
Highest schedule completed to earn a food stimulus reward during the self-administration task
Baseline, at each visit

二次結果の測定

結果測定
メジャーの説明
時間枠
Subjective effect measure: food stimulus flavor intensity
時間枠：Baseline, at each visit
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.
Baseline, at each visit
Subjective effect measure: food stimulus relaxation
時間枠：Baseline, at each visit
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.
Baseline, at each visit

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

University of Kansas

協力者

National Institute on Drug Abuse (NIDA)

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。

一般刊行物

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)

2026年9月8日

一次修了 (推定)

2030年11月1日

研究の完了 (推定)

2031年1月30日

試験登録日

最初に提出

2026年7月22日

QC基準を満たした最初の提出物

2026年8月17日

最初の投稿 (実際)

2026年8月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月11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

その他の研究ID番号

  • STUDY00151790
  • 1R01DA062585-01A1 (米国 NIH グラント/契約)

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

Participant-level data will be shared with National Addiction & Health Data Archive Program (NAHDAP).

IPD 共有時間枠

When the main outcomes are published (anticipated 2031)

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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