Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143971
• Other study ID #: 896
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: May 2020
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 20, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Overweight
• Overweight or Obesity

Intervention

Other:
• intermittent fasting diet
intermittent fasting diet
• low calorie diet
continuous low calorie diet

Locations

Country	Name	City	State
Iran, Islamic Republic of	Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Mean weight change of participants (kg) after 8 weeks of diets	at 8 weeks
Secondary	Plasma Triglycerides	Mean change in plasma triglycerides of participants after 8 weeks of diets	at 8 weeks