The Effects of Hesperidin on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03377140

Collaborator

(none)

Enrollment

Location

Arms

9.6

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study the effects of Hesperidin supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Dietary Supplement: Hesperidin Other: control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Effects of Hesperidin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Actual Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Mar 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hesperidin 2 capsuls of Hesperidin	Dietary Supplement: Hesperidin 2 capsuls
Placebo Comparator: control 2 capsuls of placebo	Other: control 2 capsuls

Arm

Intervention/Treatment

Active Comparator: Hesperidin

2 capsuls of Hesperidin

Dietary Supplement: Hesperidin

2 capsuls

Placebo Comparator: control

2 capsuls of placebo

Other: control

2 capsuls

Outcome Measures

Primary Outcome Measures

liver fibrosis [12 weeks]
assess by fibroscan

Secondary Outcome Measures

body mass index [12 weeks]
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age of 18 to 70 years
Body Mass Index (BMI) between 25-40
Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

Diabetes
Taking any kind of antibiotics two weeks before recruitment
History of alcohol consumption
pregnancy or lactation
Professional athletes
Other liver disease (viral/etc)
Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
Following program to lose weight in recent 3 mo
A history of hypothyroidism or Cushing's syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Nutrition and Food Technology Research Institute	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute

ClinicalTrials.gov Identifier:

NCT03377140

Other Study ID Numbers:

6756

First Posted:

Dec 19, 2017

Last Update Posted:

Dec 19, 2017

Last Verified:

Apr 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Dec 19, 2017