- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041752
Meal Texture and Satiety (FEED)
July 31, 2019 updated by: University Hospital, Clermont-Ferrand
Satietogenic Effect of Liquid Versus Solid Meals in Healthy Adults
The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The present study will compare the potential energy intake compensations, appetite feelings response, food reward variations and satiating responses after the ingestion of three different lunch meals: i) one classical cooked meal; ii) one iso-energetic meal consumed using a pre-prepared liquid meal; iii) one iso-energetic meal consumed using a prepared liquid meal.
This will be the first study to assess all these nutritional factors after such meals.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- CHU Clermont Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- being aged 18 to 25 years old
- Being normal weight with a BMI between 20 and 25 kg/m²
- Being registered with a social security number
Exclusion Criteria:
- Eating disorders
- Specific food allergies or habits
- being under diet
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal weight
30 healthy normal weight adults will be involved and will realize the three conditions
|
condition with a classical meal served using solid food items
condition with a liquid meal served using a powder solution
condition with a pre-prepared meal served using a liquid solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Spontaneous Energy intake measured
Time Frame: day 1 , day 8, day 15
|
spontaneous food intake will be measured ad libitum for the 12 hours that will follow the laboratory sessions (between 02:00pm to 11:59 pm).
The participants will be offered a food bag composed of items they like and proposed ad libiutm and will be asked to only conume food from this bag for the rest of the day.
Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.
|
day 1 , day 8, day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hunger feelings
Time Frame: day 1 , day 8, day 15
|
hunger area under the curve will be assessed using visual analogue scale through a the day
|
day 1 , day 8, day 15
|
Food reward
Time Frame: day 1 , day 8, day 15
|
The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)
|
day 1 , day 8, day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2019
Primary Completion (Anticipated)
October 31, 2020
Study Completion (Anticipated)
November 30, 2020
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- RBHP 2018 BOIRIE 2
- 2019-A00033-54 (Other Identifier: 2019-A00033-54)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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