The Effects of Time-Restricted Eating Model

Feeding Behavior Clinical Trial

Official title:

The Effects of Time-Restricted Eating Model on Eating Behaviors, Impulsivity and Food Intake

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960969
• Other study ID #: TRF
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Istinye University
• Contact: Elif Emiroglu
• Phone: +908502836000
• Email: elif.emiroglu[@]istinye.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Feeding Behavior
• Impulsive Behavior
• Time Restricted Feeding

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istinye University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Elif Emiroglu

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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). pii: E3770. doi: 10.3390/nu12123770. — View 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. Review. — View 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). pii: E1267. doi: 10.3390/nu12051267. — View 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;:. — View Citation

Quist JS, Jensen MM, Clemmensen KKB, Pedersen H, Bjerre N, Størling J, Blond MB, Wewer Albrechtsen NJ, Holst JJ, Torekov SS, Vistisen D, Jørgensen ME, Panda S, Brock C, Finlayson G, Færch 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 4
Primary	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.	Baseline and Week 4
Primary	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.	Baseline and Week 4
Primary	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.	Baseline and Week 4