Fasting Mimicking DietNCT06353698
Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia
A study testing fasting mimicking diet in people with Fasting Mimicking Diet and Leukemia, run by National Nutrition and Food Technology Institute at 2 sites in Iran.
Trial summary
The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting Mimicking Diet, Leukemia
- What is being tested?
- fasting mimicking diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIran
- Study dates
- 2 Jul 2023to 1 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy
- Willingness to cooperate
- BMI >18.5
Who cannot join
- diabetes
- metastases to other organ
- Unwillingness to continue the study by patients
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Azita Hekmatdoost
Tehran, Middle East, 19835
Azita Hekmatdoost, MD, PhD, +989123065084, a_hekmat2000@yahoo.com
- Recruiting
Ehsan Hejazi
Tehran, 19839-63113
Ehsan Hejazi, PhD, 00989121530775, ehsanhejazi@sbmu.ac.ir
About this study
Official title: The Effect of Fasting Mimicking Diet With Chemotherapy on the Number of Blasts and Platelets and Quality of Life in Patients With Acute Lymphoid Leukemia and Acute Myeloid Leukemia
The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.
Read the detailed description
The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia
- Conditions
- Fasting Mimicking Diet, Leukemia
- Being tested
- fasting mimicking diet
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasting mimicking dietDietary supplement
Fasting mimicking diet is limited calorie diet to enhance the effectiveness of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| fasting mimicking diet | Experimental | the intervention group that receive fasting mimicking diet with chemotherapy Receives: Dietary Supplement: fasting mimicking diet |
| control | No intervention | the control group that receive chemotherapy without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blast cell count
the number of blast cell in perpheral blood
Measured: at 4th week
Quality of life
Measuring the quality of life using EORTC QLQ questionnaire
Measured: at the beginning and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 Jul 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting Mimicking DietStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Ehsan Hejazi, PhD, Principal investigator, Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353698
- Sponsor's protocol ID
- Nnftri
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fasting Mimicking Diet With Chemotherapy on the Number of Blasts and Platelets and Quality of Life in Patients With Acute Lymphoid Leukemia and Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06353698
- Acronym / sponsor ID
- Nnftri
- Conditions
- Fasting Mimicking Diet, Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.
Detailed description
The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fasting mimicking diet | Experimental | Dietary Supplement: fasting mimicking dietthe intervention group that receive fasting mimicking diet with chemotherapy |
| control | No intervention | –the control group that receive chemotherapy without any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy
Key exclusion criteria (3 listed)
- diabetes
- metastases to other organ
- Unwillingness to continue the study by patients
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 |
|---|---|---|
| fasting mimicking dietFasting mimicking diet is limited calorie diet to enhance the effectiveness of chemotherapy | Dietary supplement | fasting mimicking diet |
Primary outcome
Blast cell count
Time frame: at 4th week
the number of blast cell in perpheral blood
Quality of life
Time frame: at the beginning and 4th week
Measuring the quality of life using EORTC QLQ questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer
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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.
Ehsan Hejazi, PhD principal investigator
Beheshti University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting mimicking diet in people with Fasting Mimicking Diet and Leukemia, run by National Nutrition and Food Technology Institute at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehsan Hejazi, PhD (00989121530775, ehsanhejazi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blast cell count (time frame: at 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.