Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Ultra-Processed Foods, Palatability, Appetite, and Gastrointestinal Transit

20. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Indiana
      • West Lafayette, Indiana, Forenede Stater, 47907
        • Purdue University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Palatable Ultra-Processed Food Meal
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.
Eksperimentel: 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.
Andet: Unpalatable Ultra-Processed Food Meal
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.
Eksperimentel: 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.
Andet: Palatable Non-Ultra-Processed Food Meal
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.
Eksperimentel: 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.
Andet: Unpalatable Non-Ultra-Processed Food Meal
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Orocecal Transit Time
Tidsramme: During each test visit, up to 4.5 hours after meal consumption
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.
During each test visit, up to 4.5 hours after meal consumption
Appetite Sensations
Tidsramme: During each test visit, up to 4.5 hours after meal consumption
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.
During each test visit, up to 4.5 hours after meal consumption
Meal Palatability Ratings
Tidsramme: During each test visit, up to 4.5 hours after meal consumption
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.
During each test visit, up to 4.5 hours after meal consumption

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Purdue University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. september 2024

Primær færdiggørelse (Faktiske)

30. april 2026

Studieafslutning (Faktiske)

30. april 2026

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-2024-450

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiseadfærd

Kliniske forsøg med Palatable Ultra-Processed Food Meal

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Canada

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner