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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04041830
Other study ID # RBHP 2019 GENTES
Secondary ID 2019-A00853-54
Status Terminated
Phase N/A
First received
Last updated
Start date December 8, 2019
Est. completion date June 25, 2021

Study information

Verified date February 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

50 lean and 50 patients with obesity between 20 and 55 years old (50% women and 50% men), will be recruited. After an evaluation of their body composition by impedance meter, and of their dietary status by questionnaires (TFEQ/DEBQ), they will be asked to perform twice the same experimental sessions. They will be asked during this session to arrive at 08:00 am after a 12-hour fast and will receive a calibrated breakfast. Before and after a lunch calibrated meal, they will be asked to perform the French version of the computerized questionnaire LFPQ. Appetite feelings will be assessed at regular intervals.


Recruitment information / eligibility

Status Terminated
Enrollment 37
Est. completion date June 25, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - eating disorders - metabolic disease such as hypertension and Type 2 diabetes

Study Design


Intervention

Behavioral:
Visit 1
the participants will fill in the LFPQ questionnaire before and after a lunch test meal
Visit 2
this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.

Locations

Country Name City State
France Chu Clermont Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK, Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Body fat mass the percentage of body fat and the quantity of fat mass will be assessed using Bio-impedance (BIA) day 0
Secondary Body fat and fat free mass the percentage of body fat free and the quantity of fat free mass will be assessed using Bio-impedance (BIA) day 0
Secondary Dietary status the level of dietary restriction/disinhibition will be assessed using the TFEQ questionnaire. day 0
Secondary Dietary status the level of dietary restriction/disinhibition will be assessed using the DEBQ questionnaire. day 0
Secondary Hunger the hunger sensation will be assessed using visual analogue scales of 150 mm. day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Secondary Satiety the Satiety sensation will be assessed using visual analogue scales of 150 mm. dday 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Secondary desire to eat the desire to eat sensation will be assessed using visual analogue scales of 150 mm. day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
Secondary Prospective Food consumption the Prospective Food consumption sensation will be assessed using visual analogue scales of 150 mm. day 1, day 1 + 30minutes, day 1+60minutes, day 1+ 90minutes , day 8, day 8 + 30minutes, day 8+60minutes, day 8+ 90minutes
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