HypertriglyceridemiaNCT04143971
Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects
A study testing intermittent fasting diet and low calorie diet in people with Hypertriglyceridemia and Overweight or Obesity, run by Shahid Beheshti University at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertriglyceridemia, Overweight or Obesity
- What is being tested?
- intermittent fasting diet and low calorie diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 2 Dec 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertriglyceridemia, Overweight or Obesity
- Being tested
- intermittent fasting diet, low calorie diet
- Keywords
- intermittent fasting, hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia, Overweight, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fasting dietOther
intermittent fasting diet
low calorie dietOther
continuous low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Continiuous Low calorie diets | Placebo comparator | Low calorie diet with daily calorie restriction Receives: Other: low calorie diet |
| Intermittent Fasting | Active comparator | Intermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie. Receives: Other: intermittent fasting diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Mean weight change of participants (kg) after 8 weeks of diets
Measured: at 8 weeks
Secondary outcomes (1)
Plasma Triglycerides
Mean change in plasma triglycerides of participants after 8 weeks of diets
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start2 Dec 2019
- Primary completion12 Mar 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143971
- Sponsor's protocol ID
- 896
- Status last verified
- May 2020
- First submitted
- 27 Oct 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33028352
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Fasting Compared to Continuous Calorie Restriction on Weight Loss & Plasma Lipids in Hypertriglyceridemic Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT04143971
- Acronym / sponsor ID
- 896
- Conditions
- Hypertriglyceridemia, Overweight or Obesity
- Keywords
- intermittent fasting, hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continiuous Low calorie diets | Placebo comparator | Other: low calorie dietLow calorie diet with daily calorie restriction |
| Intermittent Fasting | Active comparator | Other: intermittent fasting dietIntermittent fasting every other day, in which daily calorie intake will be up to 30% of required calorie. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent fasting dietintermittent fasting diet | Other | Intermittent Fasting |
| low calorie dietcontinuous low calorie diet | Other | Continiuous Low calorie diets |
Primary outcome
Weight loss
Time frame: at 8 weeks
Mean weight change of participants (kg) after 8 weeks of diets
1 secondary outcome
Plasma Triglycerides
Time frame: at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 33028352Maroofi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent fasting diet and low calorie diet in people with Hypertriglyceridemia and Overweight or Obesity, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.