Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

Shahid Beheshti University

Status: Completed

Conditions: Overweight or Obesity; Hypertriglyceridemia

Treatments: Other: low calorie diet; Other: intermittent fasting diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04143971

896

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Continiuous Low calorie diets

Placebo Comparator group

Description:

Low calorie diet with daily calorie restriction

Treatment:

Other: low calorie diet

Intermittent Fasting

Active Comparator group

Description:

Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.

Treatment:

Other: intermittent fasting diet