ClinicalTrials.gg
RecruitingNCT06353698Updated Apr 9, 2024

Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia

An interventional study of fasting mimicking diet in Fasting Mimicking Diet and Leukemia, sponsored by National Nutrition and Food Technology Institute. Recruiting at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jul 2023, registered Feb 2024).
  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Fasting Mimicking Diet
  • Leukemia

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03

In context

Leukemia

2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 1,769 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy

    • Willingness to cooperate
    • >18.5

Exclusion criteria

Exclusion Criteria:

  • diabetes
  • to other organ
  • Unwillingness to continue the study by patients
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    fasting mimicking diet

    the intervention group that receive fasting mimicking diet with chemotherapy

    Dietary Supplement: fasting mimicking diet

  • No intervention
    control

    the control group that receive chemotherapy without any intervention

Interventions

  • Dietary supplementfasting mimicking diet

    Fasting mimicking diet is limited calorie diet to enhance the effectiveness of chemotherapy

06

What researchers measure

Primary outcomes

  1. Blast cell count

    the number of blast cell in perpheral blood

    Time frame: at 4th week

  2. Quality of life

    Measuring the quality of life using EORTC QLQ questionnaire

    Time frame: at the beginning and 4th week

07

Study locations

2 of 2 sites recruiting
  • Azita Hekmatdoost
    Tehran, Middle East 19835, Iran, Islamic Republic of
    Recruiting
  • Ehsan Hejazi
    Tehran, 19839-63113, Iran, Islamic Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Apr 2024, 8 months after the start.

Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's planned 8 months is below that.

Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2024
First posted
Apr 9, 2024
StartActual
Jul 2, 2023
Primary completionEst.
Apr 1, 2024
CompletionEst.
May 1, 2024
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06353698
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Principle Investigator, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Apr 9, 2024
Start date
Jul 2, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Apr 9, 2024

Study contacts

Ehsan Hejazi, PhD
Contact
ehsanhejazi@gmail.com
00989121530775
Azita Hekmatdoost
Contact
a_hekmat2000@yahoo.com
009123065084
Ehsan Hejazi, PhD
principal investigator · Beheshti University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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