- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06515639
Classic vs. High-Fat Intermittent Fasting Effects
July 19, 2024 updated by: Emre Batuhan Kenger, Istanbul Bilgi University
Classic vs. High-Fat Intermittent Fasting: Impacts on Body Composition, Eating Behavior, and Diet Satisfaction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey, 41400
- Gebze Municipality Family Counseling Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-65 years old
- no chronic disease
- female
- volunteering
Exclusion Criteria:
- hypoglycemia
- eating disorders
- pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Classic IF diet
The 16:8 intermittent fasting model, 45-60% carbohydrates, 10-15% protein, and 25-30% fat dietary model applied.
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The 16:8 intermittent fasting model was applied for six weeks.
Time restrictions were tailored to fit the participants' lifestyles, with feeding times set between 10:00-12:00 and 18:00-20:00 for all participants.
The classic intermittent fasting diet was planned with a macronutrient distribution of 45-60% carbohydrates, 10-15% protein, and 25-30% fat.
Additionally, total energy intake was reduced by 500-750 kcal.
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Experimental: Low carb-High fat IF diet
The 16:8 intermittent fasting model, 10-30% carbohydrates and 50-65% fat dietary model applied.
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The 16:8 intermittent fasting model was applied for six weeks.
Time restrictions were tailored to fit the participants' lifestyles, with feeding times set between 10:00-12:00 and 18:00-20:00 for all participants.The low carb-high fat intermittent fasting diet included 10-30% carbohydrates and 50-65% fat.Additionally, total energy intake was reduced by 500-750 kcal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: six weeks
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measurements of total body weight
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six weeks
|
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Body composition
Time Frame: six weeks
|
measurements of body mass index (BMI)
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six weeks
|
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Body composition
Time Frame: six weeks
|
measurements of fat mass
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six weeks
|
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Body composition
Time Frame: six weeks
|
measurements of muscle mass
|
six weeks
|
|
Body composition
Time Frame: six weeks
|
measurements of fat percentage
|
six weeks
|
|
diet satisfaction
Time Frame: six weeks
|
A number of questions are necessary for clinicians to evaluate their patients' or clients' diet satisfaction, as well as their compliance with the diet, based on their responses.
The Diet Satisfaction Scale is designed to assess satisfaction with various aspects of any diet, such as hunger levels, desire to eat, food preparation, enjoyment, ease of adherence at home and away, food variety, budget compatibility, contribution to physical health, and sustainability.
The scale was developed by Jospe et al, and its Turkish validity and reliability were established by Eskici and Yilmaz.
It consists of 9 items with 5-point Likert-type response options ranging from 1 (strongly disagree) to 5 (strongly agree).
Notably, the first item is reverse-scored (1=5, 2=4, 3=3, 4=2, and 5=1).
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six weeks
|
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behavioral and cognitive components of eating
Time Frame: six weeks
|
The Three-Factor Eating Scale, used to measure the behavioral and cognitive components of eating, was developed by Cappelleri and colleagues.
Its validity and reliability in Turkish were established by Karakus et al.
The questionnaire comprises three factors: Uncontrolled Eating (UE), Cognitive Restraint (CR), and Emotional Eating (EE).
Uncontrolled Eating (UE) refers to losing control over eating due to hunger or external stimuli and includes 9 items, with scores ranging from 9 to 36.
Cognitive Restraint (CR) refers to the conscious restriction of food intake to control body shape and weight, encompassing 6 items, with scores ranging from 6 to 24.
Emotional Eating (EE) examines overeating in response to negative emotional states such as anger, sadness, or stress, and includes 6 items, with scores ranging from 6 to 24.
A higher score in any sub-factor indicates a greater dominance of the corresponding eating behavior.
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six weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Flaskerud JH. Mood and food. Issues Ment Health Nurs. 2015 Apr;36(4):307-10. doi: 10.3109/01612840.2014.962677. No abstract available.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Actual)
April 1, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
July 16, 2024
First Submitted That Met QC Criteria
July 19, 2024
First Posted (Actual)
July 23, 2024
Study Record Updates
Last Update Posted (Actual)
July 23, 2024
Last Update Submitted That Met QC Criteria
July 19, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IFLOWCARB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data will be shared if requested by the authors.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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