The Effects of Time-Restricted Eating Model

Sponsor
Elif Emiroğlu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04960969
Collaborator
(none)
30
1
2
19
1.6

Study Details

Study Description

Brief Summary

There is increasing evidence of the effects of the time-restricted diet model based on the daily intake of energy within a period of 8-12 hours on body weight control and metabolic parameters. There is no study on the potential effects of this nutritional model, which is thought to be an effective strategy in struggling with metabolic syndrome, on individuals' eating behavior and impulsivity levels. This study, which aims to evaluate the effects of time- restricted diet strategy on food intake, eating attitude and behavior and impulsivity level in adults, is a mixed method, randomized controlled intervention study. Thirty adult individuals between the ages of 18-65 will be included in this study, which will be carried out between 31.05.2021-31.12.2021 in Istinye University. Participants will be divided into 2 groups: the intervention group (n = 15) will apply a time-restricted nutrition model for 4 weeks, and no intervention will be applied to the control group (n = 15). Participants' food intake before and after the intervention period will be evaluated with a 3-day food intake record, their eating attitudes will be evaluated with the Eating Attitude Test (EAT-26), their impulsivity levels will be evaluated with the Barratt Impulsiveness Scale-Short Form (BIS-11-SF) and Go / NoGo test, and their eating behaviors will be evaluated with the Three Factor Eating Questionnaire (TFEQ-R21). At the end of the research, all individuals in the intervention group will be interviewed in depth and their experiences regarding the process will be recorded. IBM SPSS 22 program will be used in the analysis of all quantitative data, and the MAXQDA-12 program will be used in the analysis of qualitative data. The data obtained from this research will clear up the applicability of the time- restricted diet model and its effects on eating behaviors of adults.

Condition or Disease Intervention/Treatment Phase
  • Other: Time-restricted feeding for 4 weeks
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effects of Time-Restricted Eating Model on Eating Behaviors, Impulsivity and Food Intake
Actual Study Start Date :
May 31, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Time-restricted Feeding Group

Participants will apply time-restricted feeding (8 hours/day) for 28 days.

Other: Time-restricted feeding for 4 weeks
Participants in this group will follow a time-restricted diet for 28 days. Consumption of only non-energy drinks will be allowed for 16 hours. During the 8-hour eating period, there will be no restriction on the content of the diets.

No Intervention: Control Group

No intervention will be applied.

Outcome Measures

Primary Outcome Measures

  1. Changes in food intake of participants [Baseline and Week 4]

    The food intake of the participants will be determined by the 3-day food consumption record at the beginning and at the 4th week.

  2. Changes in impulsivity level of participants [Baseline and Week 4]

    The impulsivity of the participants will be determined by the Go/NoGo Task and Short form of Barratt Impulsiveness Scale (BIS-11-SF) at the beginning and at the 4th week.

  3. Changes in eating attitude of participants [Baseline and Week 4]

    The eating attitude of the participants will be determined by the Eating Attitude Test (EAT-26) at the beginning and at the 4th week.

  4. Changes in eating behaviors of participants [Baseline and Week 4]

    The eating behaviors of the participants will be determined by the Three Factor Eating Questionnaire (TFEQ-R21) at the beginning and at the 4th week.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being between the ages of 18-65,

  • Body mass index (BMI) ≥ 18.5 kg/m2,

  • Routine eating window ≥10 hours (including all energy-containing meals and drinks),

  • To agree to participate in the research voluntarily.

Exclusion Criteria:
  • Age <18 or >65,

  • BMI <18.5 kg/m2,

  • To have applied nutritional therapy for weight loss or medical treatment in the last 6 months,

  • Being in pregnancy or lactation period,

  • Working the night shift or the partner working the night shift (if it affects the participant's sleep and nutritional status),

  • Having a known neurological or psychological disorder,

  • Declaring that have a history of eating disorder in the last 3 months,

  • Weight change of ≥ 5 kg in the last 3 months,

  • Having an uncontrolled medical problem (cardiovascular, pulmonary, rheumatological, hematological, oncological, gastrointestinal, psychiatric, endocrinological, etc.)

  • Receiving medical treatment that may have a significant impact on glucose metabolism, appetite or energy balance,

  • Being on antidepressant treatment,

  • Having a history of bariatric surgery,

  • Having celiac, crohn's or ulcerative colitis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istinye University Istanbul Turkey

Sponsors and Collaborators

  • Elif Emiroğlu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elif Emiroğlu, Lecturer, Istinye University
ClinicalTrials.gov Identifier:
NCT04960969
Other Study ID Numbers:
  • TRF
First Posted:
Jul 14, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021