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Status unknownNCT04369521Updated Apr 30, 2020

Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease

An interventional study of low free sugar diet in Nonalcoholic Fatty Liver Disease, sponsored by National Nutrition and Food Technology Institute. Status unknown at 2 sites in Iran. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-30.

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

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

02

Conditions studied

  • Nonalcoholic Fatty Liver Disease
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
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

  1. Age of 18 to 60 years
  2. Body Mass Index (BMI) between 25-40
  3. Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion criteria

Exclusion Criteria:

  1. Alcohol consumption
  2. pregnancy or lactation
  3. Other liver disease (viral,cirrhosis,...)
  4. Use of drugs such as phenytoin,tamoxifen,lithium
  5. A history of Cancer, autoimmune disease,Renal disease \& Celiac disease, hypothyroidism or Cushing's syndrome
  6. Lack of desire to continue studying
  7. Have to use antibiotics with hepatotoxic drugs while studying
  8. Non-compliance with diet
05

Study design

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

Study arms

  • Experimental
    Intervention

    low free sugar diet with nutrition and exercise recommendation

    Other: low free sugar diet

  • No intervention
    control

    regular diet with nutrition and exercise recommendation

Interventions

  • Otherlow free sugar diet

    low free sugar diet with nutrition and exercise recommendation

06

What researchers measure

Primary outcomes

  1. ALT

    serum level of Alanine transaminase

    Time frame: 12 weeks

  2. AST

    serum level of Aspartate transaminase

    Time frame: 12 weeks

  3. GGT

    serum level of Gamma glutaminase

    Time frame: 12 weeks

  4. TG

    serum level of Triglyceride

    Time frame: 12 weeks

  5. Total cholesterol

    serum level of total cholesterol

    Time frame: 12 weeks

  6. LDL-c

    serum level of LDL-Cholesterol

    Time frame: 12 weeks

  7. HDL-c

    serum level of HDL-Cholesterol

    Time frame: 12 weeks

  8. FBS

    serum level of Fasting blood sugar

    Time frame: 12 weeks

  9. Insulin

    serum level of Insulin

    Time frame: 12 weeks

  10. hs-CRP

    Serum level of high-sensitive C-reactive protein

    Time frame: 12 weeks

  11. TNF-a

    Serum level of Tumor necrosis factor-a

    Time frame: 12 weeks

  12. NF-kb

    Activity of Nuclear factor-B in peripheral monocellular cells

    Time frame: 12 weeks

  13. Liver fibrosis

    Liver fibrosis according to fibroscan exam

    Time frame: 12 weeks

07

Study locations

2 of 2 sites recruiting
  • Azita Hekmatdoost
    Tehran, Middle East 19835, Iran
    Recruiting
  • National Nutrition and Food Technology Research Institute
    Tehran, Iran
    • Azita Hekmatdoost, MD, Ph.D · Contact
    Recruiting
08

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 Oct 2019 (actual). Primary completion is estimated for May 2020, 6 months after the start.

Of 323 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 6 months is below that.

Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

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

Registered
Apr 27, 2020
First posted
Apr 30, 2020
StartActual
Oct 23, 2019
Primary completionEst.
May 9, 2020
CompletionEst.
Jul 21, 2020
Last update
Apr 30, 2020
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 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04369521
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (principal investigator, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Apr 30, 2020
Start date
Oct 23, 2019
Primary completion
May 9, 2020 (estimated)
Completion
Jul 21, 2020 (estimated)
Last update
Apr 30, 2020

Study contacts

Azita Hekmatdoost, MD,PhD
Contact
a_hekmat2000@yahoo.com
+989123065084

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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