Clinical trial NCT04960969: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Time Restricted Feeding
Feeding Behavior
Impulsive Behavior
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Changes in food intake of participants
timeFrame: Baseline and Week 4
measure: Changes in impulsivity level of participants
timeFrame: Baseline and Week 4
measure: Changes in eating attitude of participants
timeFrame: Baseline and Week 4
measure: Changes in eating behaviors of participants
timeFrame: Baseline and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
Study officials:
References:
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.
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.
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.
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.
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.
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.