NCT04041752

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

July 29, 2019

Last Update Submit

July 31, 2019

Conditions

Healthy Normal Weight

Keywords

Meal textureAppetiteEnergy compensationFood reward

Outcome Measures

Primary Outcomes (1)

  • Change in Spontaneous Energy intake measured

    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 Outcomes (2)

  • Hunger feelings

    day 1 , day 8, day 15

  • Food reward

    day 1 , day 8, day 15

Study Arms (1)

Normal weight

EXPERIMENTAL

30 healthy normal weight adults will be involved and will realize the three conditions

Behavioral: SOLIDBehavioral: LIQUID_PBehavioral: LIQUID_L

Interventions

SOLIDBEHAVIORAL

condition with a classical meal served using solid food items

Normal weight
LIQUID_PBEHAVIORAL

condition with a liquid meal served using a powder solution

Normal weight
LIQUID_LBEHAVIORAL

condition with a pre-prepared meal served using a liquid solution.

Normal weight

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Eating disorders
  • Specific food allergies or habits
  • being under diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants complete the same conditions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

August 1, 2019

Primary Completion

October 31, 2020

Study Completion

November 30, 2020

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

FR(1)