Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

Not Applicable

Completed

• Conditions: Overweight or Obesity; Hypertriglyceridemia
• Interventions: Other: intermittent fasting diet; Other: low calorie diet

• Registration Number: NCT04143971
• Lead Sponsor: Shahid Beheshti University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-27
• Study First Posted: 2019-10-30
• Study Start: 2019-12-02
• Primary Completion: 2020-03-12
• Status Verified: 2020-05
• Study Completion: 2020-05-20
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting	intermittent fasting diet	Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.
Continiuous Low calorie diets	low calorie diet	Low calorie diet with daily calorie restriction

Primary Outcome Measures

Name	Time	Method
Weight loss	at 8 weeks	Mean weight change of participants (kg) after 8 weeks of diets

Secondary Outcome Measures

Name	Time	Method
Plasma Triglycerides	at 8 weeks	Mean change in plasma triglycerides of participants after 8 weeks of diets

Trial Locations

Locations (1)

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of