Effect of time restricted feeding on anthropometric measures, body composition, eating behavior, stress, brain derived neurotrophic factor (BDNF) levels, and lipopolysaccharide binding protein (LBP) levels in food addicted obese women: a randomized clinical trial
determination of the effect of time restricted feeding on anthropometric measures, body composition, eating behavior, stress, brain derived neurotrophic factor levels, and lipopolysaccharide binding protein levels in food addicted obese women
Design
participants first divided into two groups based on Body Mass Index (BMI) grade-1 obesity BMI=29.9-34.9 and grade-2 obesity BMI=34.9-39.9, then individuals in each group is assigned to intervention orthe control group by randomized blocking method.
Settings and conduct
The population of this study obese women referred to the nutrition clinic of shahid beheshti university. Sample size 60 subjects (30 in the intervention group and 30 in the control group). Intervention Individuals will take weight loss diet with or without time restriction for 8 weeks based on the group they are in
Participants/Inclusion and exclusion criteria
inclusion criteria: Body Mass Index between 30- 39.9 kg/m2 inclination to participate in the study confirmation of food addiction based on YALE food addiction questionnaire age between 20-60y. Exclusion criteria having any kind of disease being on a weight loss diet in the last 2 months pregnancy or lactation menopause smoking using vitamin and/or mineral supplements continuous using any kind of drugs continuous using (more than 1 time/week) any probiotic products in the last month using any kind of antibiotics in the last three months using weight or appetite reducing drugs Sports activity that lasted more than three weeks from the start
Intervention groups
Individuals will receive weight loss diet with an intake time restricted to 10 am to 8 pm in intervention group or weight loss diet without time restriction in intake in control group for 8 weeks based on the group they are in.
Main outcome variables
weight, body composition, eating behavior, stress, BDNF and LBP levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015968N7
Registration date:2020-10-25, 1399/08/04
Registration timing:registered_while_recruiting
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Atoosa Saidpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of nutrition
Country
Iran (Islamic Republic of)
Phone
-
Email address
a.saidpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of time restricted feeding on anthropometric measures, body composition, eating behavior, stress, brain derived neurotrophic factor (BDNF) levels, and lipopolysaccharide binding protein (LBP) levels in food addicted obese women: a randomized clinical trial
Public title
Effect of time restricted feeding on anthropometric measures, body composition, eating behavior, stress, brain derived neurotrophic factor (BDNF) levels, and lipopolysaccharide binding protein (LBP) levels in food addicted obese women: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI between 30- 39.9 kg/m2
inclination to participate in the study
confirmation of food addiction based on YALE food addiction questionaire
age between 20-60y
Exclusion criteria:
having any kind of disease
beeing on a weight loss diet in the last 2 months
pregnancy or lactation
menopause
smoking
using vitamin and/or mineral supplements
continuous using any kind of drugs
continuous using (more than 1 time/week) any probiotic products ( probiotic supplement, probiotic yogurt or probiotic cheese) in the last month
using any kind of antibiotics in the last three months
using weight or appetite reducing drugs
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants were classified into two groups with obesity grade A (30-34.9) and obesity grade 2 (34.9-39.9) by stratified blocked randomization method and based on BMI and randomly assigned to One of the groups TRF or control group. Separate randomization is done based on BMI within each group. The size of the blocks is 4, with two assignments to the intervention group (A) and two allocations to the control group (B). There are 6 different permutations of AABB, ABAB, BBAA, BABA, ABBA, BAAB.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences