NCT06853249

Brief Summary

The aim of the study is to investigate the effect of liquid versus semi-solid meals on the regulation of energy balance in healthy young adults.The main questions it aims to answer are:

  • Does a protein-rich liquid meal result in less satiety and therefore higher ad libitum energy intake at the next meal than an isocaloric oatmeal with the same macronutrient ratio?
  • Is the consumption of a protein-rich liquid meal as a beverage in addition to an ad libitum oatmeal less compensated within the meal and at the next meal and provides thus a higher ad libitum energy intake than an isovolumetric noncaloric soft drink in addition to an ad libitum oatmeal? Researchers will compare a protein-rich liquid meal to an isocaloric oatmeal with matched macronutrient composition to answer the first question. Researchers will compare a protein-rich liquid meal + oatmeal to a noncaloric softdrink (water with sucralose and flavoring) + oatmeal to answer the second question. Participants will:
  • spend 4 intervention days in a metabolic chamber (whole room indirect calorimeter)
  • consume pre-definied preloads for breakfast and ad libitum lunch meals on 4 intervention days

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 13, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

food textureappetite controlwhole room indirect calorimetry (WRIC)energy balancegastric emptyingad libitum energy intakeliquid meals

Outcome Measures

Primary Outcomes (1)

  • ad libitum energy intake

    measured during preload and lunch \[kcal\] following the preload in both arms

    for 9 hours after the consumption of the preloads

Secondary Outcomes (8)

  • gastric emptying

    for 4 hours after the consumption of the isocaloric preloads

  • eating rate at lunch

    at 5 hours after consumption of the preload

  • number of chews per bite at lunch

    at 5 hours after consumption of the preload

  • serum ghrelin concentrations

    for 3 hours after consumption of the isocaloric preloads

  • serum peptide-YY (PYY) concentrations

    for 3 hours after consumption of the isocaloric preloads

  • +3 more secondary outcomes

Study Arms (2)

isocaloric preload

EXPERIMENTAL

In this arm of the study, participants receive two different isocaloric preloads for breakfast, one as a liquid meal and one as oatmeal.

Other: liquid mealOther: semi-solid meal

ad libitum preload

EXPERIMENTAL

In this arm of the study, participants are given two different isovolumetric drinks as a preload in addition to an ad libitum oatmeal breakfast. One drink is a liquid meal, the other is a non-caloric soft drink (water, sucralose, flavour).

Other: caloric drink + semi-solid mealOther: non-caloric drink + semi-solid meal

Interventions

An isocaloric amount (500 kcal) of a commercially available liquid meal with a matched macronutrient composition is consumed. After 5 hours, lunch is eaten ad libitum.

isocaloric preload

An isocaloric amount (500 kcal) of a commercially available semi-solid oatmeal with a matched macronutrient composition is consumed. After 5 hours, lunch is eaten ad libitum.

isocaloric preload

A predefined amount of a caloric drink (= liquid meal) together with an ad libitum amount of a semi-solid meal is consumed. After 5 hours, lunch is eaten ad libitum.

ad libitum preload

A predefined amount of a non-caloric drink (= water, sucralose, flavor) together with an ad libitum amount of a semi-solid meal is consumed. After 5 hours, lunch is eaten ad libitum.

ad libitum preload

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfemale, male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males and females
  • Body Mass Index between 19-35 kg/m2
  • low to medium habitual physical activity
  • women with regular menstrual cycle (during intervention in follicular phase)

You may not qualify if:

  • smoking (cigarettes + cannabis)
  • chronic illnesses
  • regular intake of medication
  • Anemia and/or iron deficiency
  • food allergies / intolerances
  • vegans
  • regular high physical activity (exercise \>1 hour/d)
  • current weight loss diet / weight loss of \>5 kg in the last 3 months
  • restraint eaters (according to the German version of the 'Three-Factor-Eating-Questionnaire', Stunkard und Messick (1985))
  • active participation in another trial
  • pregnant / lactating women
  • persons incapable of giving informed legal consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kiel University, Institute of Human Nutrition

Kiel, Germany

Location

Study Officials

  • Anja Bosy-Westphal, PhD, MD

    University of Kiel, Department of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinding of participants to the actual primary outcome parameters to avoid energy intake bias
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The trial consists of two arms, each with two interventions. All participants will receive all interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Department of Human Nutrition

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 28, 2025

Study Start

April 1, 2025

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to the privacy statement in the subject information form, data may not be publicly available but might be available upon reasonable request.

Locations