Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

Study Overview
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Brief Summary
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some studies have shown similar effects of intermittent fasting and continuous caloric restriction on body weight and plasma lipid profile, but there is still a wide controversy. Therefore,due to limited human studies and the lack of a study on hypertriglyceridemic patients, the present study aimed to determine the effects of using low-calorie diets in comparison with continuous caloric restriction on weight loss and plasma lipid profile in obese or overweight hypertriglyceridemic patients.

Detailed Description
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a randomized clinical trial will be conducted in National Nutrition and Food Technology Research Institute, Tehran, Iran. after the review of inclusion and exclusion criteria, a written consent form will be completed. the participants will be 90 hypertriglyceridemic patients aged between 18-60. half of the participants will be under intermittent low-calorie diet which they will have 3 alternate days in the week eating only 30% of their total energy requirement and on the other days of the week they receive a total calorie of 100% of their energy requirement , therefore there will be a total of -210% TEE reduction in their received energy in the week. the other group will be under continuous calorie restriction meaning on all the days of the week they will be eating 70% of their total energy requirement resulting in a total of -210% TEE reduction in their received energy in the week. both groups will receive 3 consultation sessions with a nutritionist, also to prevent any deficiency, multi-vitamin-mineral supplements will be given to both groups participants.

Official Title
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Effects of Intermittent Fasting Compared to Continuous Calorie Restriction on Weight Loss & Plasma Lipids in Hypertriglyceridemic Overweight or Obese Subjects

Conditions
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Hypertriglyceridemia, Overweight or Obesity

Intervention / Treatment
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* Other: intermittent fasting diet
* Other: low calorie diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hypertriglyceridemic : TG>150 mg/dL BMI>24.9 age 18-60 non-smoker haven't been under any diet at least 3 months before participating in the study not starting any new exercise program or changing the previous exercise while in the study Exclusion Criteria: chronic kidney disease stage 3-5 consuming Insulin or Insulin-inducing drugs. consuming triglycerides lowering drugs or Omega 3 a history of cholecystitis Heart arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Continiuous Low calorie diets<br>Low calorie diet with daily calorie restriction | Other: low calorie diet<br>* continuous low calorie diet<br>|
| Active Comparator: Intermittent Fasting<br>Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie. | Other: intermittent fasting diet<br>* intermittent fasting diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Mean weight change of participants (kg) after 8 weeks of diets | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Triglycerides | Mean change in plasma triglycerides of participants after 8 weeks of diets | at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent fasting, hypertriglyceridemia