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Completed

NCT Number: NCT06515639

Classic vs. High-Fat Intermittent Fasting Effects

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.

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Key information

Conditions

Obesity Behavior Behavior, Animal Body Weight Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gebze Municipality Family Counseling Center

Istanbul, 41400, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • hypoglycemia
  • eating disorders
  • pregnant and lactating women

Treatment and study plan

Diet therapy for Classic IF diet group

Other

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 group

Other

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.

Primary outcomes

  1. Body composition

    Time frame: six weeks

    measurements of total body weight

  2. Body composition

    Time frame: six weeks

    measurements of body mass index (BMI)

  3. Body composition

    Time frame: six weeks

    measurements of fat mass

  4. Body composition

    Time frame: six weeks

    measurements of muscle mass

  5. Body composition

    Time frame: six weeks

    measurements of fat percentage

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Bilgi University

Other

Registry information

Official study title

Classic vs. High-Fat Intermittent Fasting: Impacts on Body Composition, Eating Behavior, and Diet Satisfaction

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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