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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedMay 27, 2020
May 1, 2020
3 months
October 27, 2019
May 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
Mean weight change of participants (kg) after 8 weeks of diets
at 8 weeks
Secondary Outcomes (1)
Plasma Triglycerides
at 8 weeks
Study Arms (2)
Continiuous Low calorie diets
PLACEBO COMPARATORLow calorie diet with daily calorie restriction
Intermittent Fasting
ACTIVE COMPARATORIntermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741, Iran
Related Publications (1)
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.
PMID: 33028352DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 27, 2019
First Posted
October 30, 2019
Study Start
December 2, 2019
Primary Completion
March 12, 2020
Study Completion
May 20, 2020
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share