AzTrials
AzTrials

ObesityNCT06515639

Classic vs. High-Fat Intermittent Fasting Effects

A study testing Diet therapy for Classic IF diet group and Diet therapy for low carb-High fat IF diet group in people with Obesity, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Diet therapy for Classic IF diet group and Diet therapy for low carb-High fat IF diet group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2024to 15 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • hypoglycemia
  • eating disorders
  • pregnant and lactating women

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gebze Municipality Family Counseling Center

    Istanbul, 41400

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Obesity
Being tested
Diet therapy for Classic IF diet group, Diet therapy for low carb-High fat IF diet group
Keywords
Intermittent fasting diet, body composition, eating behavior, diet satisfaction
Medical subject headings
Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet therapy for Classic IF diet groupOther

    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.

  • Diet therapy for low carb-High fat IF diet groupOther

    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.

Study groups in NCT06515639
Study groupRoleWhat they receive
Classic IF dietExperimentalThe 16:8 intermittent fasting model, 45-60% carbohydrates, 10-15% protein, and 25-30% fat dietary model applied.
Receives: Other: Diet therapy for Classic IF diet group
Low carb-High fat IF dietExperimentalThe 16:8 intermittent fasting model, 10-30% carbohydrates and 50-65% fat dietary model applied.
Receives: Other: Diet therapy for low carb-High fat IF diet group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    measurements of total body weight

    Measured: six weeks

  2. Body composition

    measurements of body mass index (BMI)

    Measured: six weeks

  3. Body composition

    measurements of fat mass

    Measured: six weeks

  4. Body composition

    measurements of muscle mass

    Measured: six weeks

  5. Body composition

    measurements of fat percentage

    Measured: six weeks

  6. diet satisfaction

    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).

    Measured: six weeks

  7. behavioral and cognitive components of eating

    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.

    Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Apr 2024
  4. Study completion15 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06515639
Sponsor's protocol ID
IFLOWCARB
Status last verified
Jul 2024
First submitted
16 Jul 2024
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data will be shared if requested by the authors.

Publications

  • 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.

    PubMed 32213213

  • 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.

    PubMed 32052997

  • 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.

    PubMed 32885229

  • Flaskerud JH. Mood and food. Issues Ment Health Nurs. 2015 Apr;36(4):307-10. doi: 10.3109/01612840.2014.962677. No abstract available.

    PubMed 25988966

  • 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.

    PubMed 32060194

  • 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.

    PubMed 19399021

  • 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.

    PubMed 31680438

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Diet therapy for Classic IF diet group and Diet therapy for low carb-High fat IF diet group in people with Obesity, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: six weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06515639, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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