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

NCT ID: NCT04369521

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2020-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

low free sugar diet with nutrition and exercise recommendation

Group Type EXPERIMENTAL

low free sugar diet

Intervention Type OTHER

low free sugar diet with nutrition and exercise recommendation

control

regular diet with nutrition and exercise recommendation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low free sugar diet

low free sugar diet with nutrition and exercise recommendation

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azita Hekmatdoost

Tehran, Middle East, Iran

Site Status RECRUITING

National Nutrition and Food Technology Research Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Azita Hekmatdoost, MD,PhD

Role: CONTACT

Phone: +989123065084

Email: [email protected]

Facility Contacts

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Azita Hekmatdoost, MD, PhD

Role: primary

Azita Hekmatdoost, MD, Ph.D

Role: primary

Other Identifiers

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22300

Identifier Type: -

Identifier Source: org_study_id