Clinical trial NCT06515639: Classic vs. High-Fat Intermittent Fasting Effects
Official title: Classic vs. High-Fat Intermittent Fasting: Impacts on Body Composition, Eating Behavior, and Diet Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Intermittent fasting diet
body composition
eating behavior
diet satisfaction
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poor eating habits contribute to weight gain and obesity, leading to numerous metabolic issues such as diabetes and cardiovascular diseases. The treatment of obesity involves lifestyle interventions that include dietary and nutritional modifications, physical activity, and behavioral therapy. Literature supports both carbohydrate and fat restriction in the treatment of obesity. In low-carbohydrate diets, less than 40% of energy is sourced from carbohydrates.Besides the dietary model, individual eating behavior can also influence the diet's outcomes. There is a significant relationship between eating behavior and food choices. Given that food choices can impact diet satisfaction, evaluating eating behavior is important when assessing dietary compliance.The literature includes studies demonstrating the effects of a classic intermittent fasting diet. However, no studies have compared the potential effects of intermittent fasting models based on the macronutrient distribution within their content. Therefore, this study aims to evaluate the effects of high-fat, low-carbohydrate intermittent fasting versus classical intermittent fasting on body composition, eating behavior, and diet satisfaction.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* no chronic disease
* female
* volunteering

Exclusion Criteria:

* hypoglycemia
* eating disorders
* pregnant and lactating women

Primary outcomes:
measure: Body composition
timeFrame: six weeks
measure: Body composition
timeFrame: six weeks
measure: Body composition
timeFrame: six weeks
measure: Body composition
timeFrame: six weeks
measure: Body composition
timeFrame: six weeks
measure: diet satisfaction
timeFrame: six weeks
measure: behavioral and cognitive components of eating
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gebze Municipality Family Counseling Center
Study officials:
References:
citation: Konttinen H. Emotional eating and obesity in adults: the role of depression, sleep and genes. Proc Nutr Soc. 2020 Aug;79(3):283-289. doi: 10.1017/S0029665120000166. Epub 2020 Mar 26.
citation: Wadden TA, Tronieri JS, Butryn ML. Lifestyle modification approaches for the treatment of obesity in adults. Am Psychol. 2020 Feb-Mar;75(2):235-251. doi: 10.1037/amp0000517.
citation: Willems AEM, Sura-de Jong M, van Beek AP, Nederhof E, van Dijk G. Effects of macronutrient intake in obesity: a meta-analysis of low-carbohydrate and low-fat diets on markers of the metabolic syndrome. Nutr Rev. 2021 Mar 9;79(4):429-444. doi: 10.1093/nutrit/nuaa044.
citation: Flaskerud JH. Mood and food. Issues Ment Health Nurs. 2015 Apr;36(4):307-10. doi: 10.3109/01612840.2014.962677. No abstract available.
citation: Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
citation: Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Lowe MR, Karlsson J. Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants. Int J Obes (Lond). 2009 Jun;33(6):611-20. doi: 10.1038/ijo.2009.74. Epub 2009 Apr 28.
citation: Karakuş SS, Yıldırım H, Büyüköztürk Ş. Adaptation of the Three-Factor Eating Questionnaire into Turkish: A validity and reliability study. Prev Med Bull 2016;15, 229-237.
citation: Jospe MR, Haszard JJ, Taylor RW, Freedhoff Y. A tool for assessing the satisfaction of a diet: Development and preliminary validation of the Diet Satisfaction Score. Nutr Diet. 2020 Apr;77(2):268-273. doi: 10.1111/1747-0080.12591. Epub 2019 Nov 3.
citation: Eskici G, Yılmaz SK. Validity and reliability study of the Turkish form of the Diet Satisfaction Scale. Ankara Sağlık Bilim Derg 2021; 10, 35-45.