NCT04041830

Brief Summary

While Food reward is an important component of the appetite control to consider, there is actually no tool that has been developed in French to perform its evaluation. The Leeds Food Preference Questionnaire (LFPQ) is a validated and recognized tool to assess food reward, being however developed for British populations. The aim of this work is to validate a French version of the LFPQ among lean and obese adults.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

July 29, 2019

Last Update Submit

February 16, 2022

Conditions

Keywords

AppetiteFood RewardMethodological approach

Outcome Measures

Primary Outcomes (1)

  • Change in Food reward

    The participants will be asked to complete the developed French version of the computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008).

    day 1 , day 8

Secondary Outcomes (8)

  • Body fat mass

    day 0

  • Body fat and fat free mass

    day 0

  • Dietary status

    day 0

  • Dietary status

    day 0

  • Hunger

    day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes

  • +3 more secondary outcomes

Study Arms (2)

NW (Normal Weight)

EXPERIMENTAL

20 to 55 years old lean adults

Behavioral: Visit 1Behavioral: Visit 2

OBESE

EXPERIMENTAL

20 to 55 years old adults with obesity

Behavioral: Visit 1Behavioral: Visit 2

Interventions

Visit 1BEHAVIORAL

the participants will fill in the LFPQ questionnaire before and after a lunch test meal

NW (Normal Weight)OBESE
Visit 2BEHAVIORAL

this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.

NW (Normal Weight)OBESE

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 30 and 38 kg.m² for the obese patients and 20 and 25 for the lean ones.
  • registered to the national social security system
  • Signed consent

You may not qualify if:

  • eating disorders
  • metabolic disease such as hypertension and Type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Elodie Gentes

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

December 8, 2019

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations