Nonalcoholic Fatty Liver DiseaseNCT04369521
Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease
A study testing low free sugar diet in people with Nonalcoholic Fatty Liver Disease, run by National Nutrition and Food Technology Institute at 2 sites in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- low free sugar diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIran
- Study dates
- 23 Oct 2019to 21 Jul 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
- Age of 18 to 60 years
- Body Mass Index (BMI) between 25-40
- Sonographic findings compatible with hepatic steatosis (degree 2 or more)
Who cannot join
- Alcohol consumption
- pregnancy or lactation
- Other liver disease (viral,cirrhosis,...)
- Use of drugs such as phenytoin,tamoxifen,lithium
- A history of Cancer, autoimmune disease,Renal disease \& Celiac disease, hypothyroidism or Cushing's syndrome
- Lack of desire to continue studying
- Have to use antibiotics with hepatotoxic drugs while studying
- Non-compliance with diet
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
National Nutrition and Food Technology Research Institute
Tehran
Azita Hekmatdoost, MD, Ph.D
About this study
Official title: Evaluation of 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
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.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- low free sugar diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low free sugar dietOther
low free sugar diet with nutrition and exercise recommendation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | low free sugar diet with nutrition and exercise recommendation Receives: Other: low free sugar diet |
| control | No intervention | regular diet with nutrition and exercise recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT
serum level of Alanine transaminase
Measured: 12 weeks
AST
serum level of Aspartate transaminase
Measured: 12 weeks
GGT
serum level of Gamma glutaminase
Measured: 12 weeks
TG
serum level of Triglyceride
Measured: 12 weeks
Total cholesterol
serum level of total cholesterol
Measured: 12 weeks
LDL-c
serum level of LDL-Cholesterol
Measured: 12 weeks
HDL-c
serum level of HDL-Cholesterol
Measured: 12 weeks
FBS
serum level of Fasting blood sugar
Measured: 12 weeks
Insulin
serum level of Insulin
Measured: 12 weeks
hs-CRP
Serum level of high-sensitive C-reactive protein
Measured: 12 weeks
TNF-a
Serum level of Tumor necrosis factor-a
Measured: 12 weeks
NF-kb
Activity of Nuclear factor-B in peripheral monocellular cells
Measured: 12 weeks
Liver fibrosis
Liver fibrosis according to fibroscan exam
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start23 Oct 2019
- Primary completion9 May 2020 (estimated)
- Study completion21 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369521
- Sponsor's protocol ID
- 22300
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 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
- ClinicalTrials.gov ID
- NCT04369521
- Acronym / sponsor ID
- 22300
- Conditions
- Nonalcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 9 May 2020 (estimated)
- Study completion
- 21 Jul 2020 (estimated)
- First posted
- 30 Apr 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: low free sugar dietlow free sugar diet with nutrition and exercise recommendation |
| control | No intervention | –regular diet with nutrition and exercise recommendation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 to 60 years
- Body Mass Index (BMI) between 25-40
- Sonographic findings compatible with hepatic steatosis (degree 2 or more)
Key exclusion criteria (8 listed)
- Alcohol consumption
- pregnancy or lactation
- Other liver disease (viral,cirrhosis,...)
- Use of drugs such as phenytoin,tamoxifen,lithium
- A history of Cancer, autoimmune disease,Renal disease \& Celiac disease, hypothyroidism or Cushing's syndrome
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 |
|---|---|---|
| low free sugar dietlow free sugar diet with nutrition and exercise recommendation | Other | Intervention |
Primary outcome
ALT
Time frame: 12 weeks
serum level of Alanine transaminase
AST
Time frame: 12 weeks
serum level of Aspartate transaminase
GGT
Time frame: 12 weeks
serum level of Gamma glutaminase
TG
Time frame: 12 weeks
serum level of Triglyceride
Total cholesterol
Time frame: 12 weeks
serum level of total cholesterol
LDL-c
Time frame: 12 weeks
serum level of LDL-Cholesterol
HDL-c
Time frame: 12 weeks
serum level of HDL-Cholesterol
FBS
Time frame: 12 weeks
serum level of Fasting blood sugar
Insulin
Time frame: 12 weeks
serum level of Insulin
hs-CRP
Time frame: 12 weeks
Serum level of high-sensitive C-reactive protein
TNF-a
Time frame: 12 weeks
Serum level of Tumor necrosis factor-a
NF-kb
Time frame: 12 weeks
Activity of Nuclear factor-B in peripheral monocellular cells
Liver fibrosis
Time frame: 12 weeks
Liver fibrosis according to fibroscan exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low free sugar diet in people with Nonalcoholic Fatty Liver Disease, 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 8 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 30 Apr 2020. 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 Azita Hekmatdoost, MD,PhD (+989123065084, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALT (time frame: 12 weeks). The study lists 13 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 30 Apr 2020.