Clinical trial NCT04143971: Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects
Official title: Effects of Intermittent Fasting Compared to Continuous Calorie Restriction on Weight Loss & Plasma Lipids in Hypertriglyceridemic Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Overweight or Obesity
Keywords: intermittent fasting
hypertriglyceridemia
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2019-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: at 8 weeks
Secondary outcomes:
measure: Plasma Triglycerides
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Study officials:
References:
citation: Maroofi M, Nasrollahzadeh J. Effect of intermittent versus continuous calorie restriction on body weight and cardiometabolic risk markers in subjects with overweight or obesity and mild-to-moderate hypertriglyceridemia: a randomized trial. Lipids Health Dis. 2020 Oct 7;19(1):216. doi: 10.1186/s12944-020-01399-0.