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Completed

NCT Number: NCT04143971

Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Tehran, 19395-4741, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Fasting Diet

Other

intermittent fasting diet

low calorie diet

Other

continuous low calorie diet

Primary outcomes

  1. Weight loss

    Time frame: at 8 weeks

    Mean weight change of participants (kg) after 8 weeks of diets

Secondary outcomes

  1. Plasma Triglycerides

    Time frame: at 8 weeks

    Mean change in plasma triglycerides of participants after 8 weeks of diets

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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