Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects
Primary Purpose
Hypertriglyceridemia, Overweight or Obesity
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intermittent fasting diet
low calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring intermittent fasting, hypertriglyceridemia
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
Sites / Locations
- Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Continiuous Low calorie diets
Intermittent Fasting
Arm Description
Low calorie diet with daily calorie restriction
Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.
Outcomes
Primary Outcome Measures
Weight loss
Mean weight change of participants (kg) after 8 weeks of diets
Secondary Outcome Measures
Plasma Triglycerides
Mean change in plasma triglycerides of participants after 8 weeks of diets
Full Information
NCT ID
NCT04143971
First Posted
October 27, 2019
Last Updated
May 24, 2020
Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04143971
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Overweight or Obesity
Keywords
intermittent fasting, hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continiuous Low calorie diets
Arm Type
Placebo Comparator
Arm Description
Low calorie diet with daily calorie restriction
Arm Title
Intermittent Fasting
Arm Type
Active Comparator
Arm Description
Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.
Intervention Type
Other
Intervention Name(s)
intermittent fasting diet
Intervention Description
intermittent fasting diet
Intervention Type
Other
Intervention Name(s)
low calorie diet
Intervention Description
continuous low calorie diet
Primary Outcome Measure Information:
Title
Weight loss
Description
Mean weight change of participants (kg) after 8 weeks of diets
Time Frame
at 8 weeks
Secondary Outcome Measure Information:
Title
Plasma Triglycerides
Description
Mean change in plasma triglycerides of participants after 8 weeks of diets
Time Frame
at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
City
Tehran
ZIP/Postal Code
19395-4741
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33028352
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.
Results Reference
derived
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Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects
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