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The Effects of Time-Restricted Eating Model

Primary Purpose

Time Restricted Feeding, Feeding Behavior, Impulsive Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Time-restricted feeding for 4 weeks
Sponsored by
Elif Emiroğlu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Time Restricted Feeding

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istinye UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Time-restricted Feeding Group

Control Group

Arm Description

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

No intervention will be applied.

Outcomes

Primary Outcome Measures

Changes in food intake of participants
The food intake of the participants will be determined by the 3-day food consumption record at the beginning and at the 4th week.
Changes in impulsivity level of participants
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.
Changes in eating attitude of participants
The eating attitude of the participants will be determined by the Eating Attitude Test (EAT-26) at the beginning and at the 4th week.
Changes in eating behaviors of participants
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2021
Last Updated
July 13, 2021
Sponsor
Elif Emiroğlu
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1. Study Identification

Unique Protocol Identification Number
NCT04960969
Brief Title
The Effects of Time-Restricted Eating Model
Official Title
The Effects of Time-Restricted Eating Model on Eating Behaviors, Impulsivity and Food Intake
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elif Emiroğlu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Feeding Behavior, Impulsive Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted Feeding Group
Arm Type
Experimental
Arm Description
Participants will apply time-restricted feeding (8 hours/day) for 28 days.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be applied.
Intervention Type
Other
Intervention Name(s)
Time-restricted feeding for 4 weeks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in food intake of participants
Description
The food intake of the participants will be determined by the 3-day food consumption record at the beginning and at the 4th week.
Time Frame
Baseline and Week 4
Title
Changes in impulsivity level of participants
Description
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.
Time Frame
Baseline and Week 4
Title
Changes in eating attitude of participants
Description
The eating attitude of the participants will be determined by the Eating Attitude Test (EAT-26) at the beginning and at the 4th week.
Time Frame
Baseline and Week 4
Title
Changes in eating behaviors of participants
Description
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.
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Emiroğlu
Phone
+908502836000
Email
elif.emiroglu@istinye.edu.tr
Facility Information:
Facility Name
Istinye University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Emiroğlu
Phone
+90850 283 6000
Email
elif.emiroglu@istinye.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33302500
Citation
Adafer R, Messaadi W, Meddahi M, Patey A, Haderbache A, Bayen S, Messaadi N. Food Timing, Circadian Rhythm and Chrononutrition: A Systematic Review of Time-Restricted Eating's Effects on Human Health. Nutrients. 2020 Dec 8;12(12):3770. doi: 10.3390/nu12123770.
Results Reference
background
PubMed Identifier
33222161
Citation
Flanagan A, Bechtold DA, Pot GK, Johnston JD. Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. J Neurochem. 2021 Apr;157(1):53-72. doi: 10.1111/jnc.15246. Epub 2020 Dec 10.
Results Reference
background
PubMed Identifier
32847912
Citation
Quist JS, Jensen MM, Clemmensen KKB, Pedersen H, Bjerre N, Storling J, Blond MB, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Vistisen D, Jorgensen ME, Panda S, Brock C, Finlayson G, Faerch K. Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. BMJ Open. 2020 Aug 26;10(8):e037166. doi: 10.1136/bmjopen-2020-037166.
Results Reference
background
PubMed Identifier
32365676
Citation
Moon S, Kang J, Kim SH, Chung HS, Kim YJ, Yu JM, Cho ST, Oh CM, Kim T. Beneficial Effects of Time-Restricted Eating on Metabolic Diseases: A Systemic Review and Meta-Analysis. Nutrients. 2020 Apr 29;12(5):1267. doi: 10.3390/nu12051267.
Results Reference
background
PubMed Identifier
31808043
Citation
Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w. Erratum In: Rev Endocr Metab Disord. 2020 Feb 18;:
Results Reference
background
PubMed Identifier
32480126
Citation
Regmi P, Heilbronn LK. Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. iScience. 2020 Jun 26;23(6):101161. doi: 10.1016/j.isci.2020.101161. Epub 2020 May 15.
Results Reference
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The Effects of Time-Restricted Eating Model

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