Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

Effects of Intermittent Fasting Compared to Continuous Calorie Restriction on Weight Loss & Plasma Lipids 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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia; Overweight or Obesity
• Intervention / Treatment: Other: low calorie diet; Other: intermittent fasting diet

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19395-4741
    • Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Continiuous Low calorie diets; Low calorie diet with daily calorie restriction	Other: low calorie diet; continuous low calorie diet
Active Comparator: Intermittent Fasting; Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.	Other: intermittent fasting diet; intermittent fasting diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Mean weight change of participants (kg) after 8 weeks of diets	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Triglycerides	Mean change in plasma triglycerides of participants after 8 weeks of diets	at 8 weeks

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Collaborators: Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: October 27, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: hypertriglyceridemia; intermittent fasting
• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Overweight; Hypertriglyceridemia
• Other Study ID Numbers: 896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No