The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-02-01

Brief Summary

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To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) 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.

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Detailed Description

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Conditions

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Non Alcoholic Steatohepatitis

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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hesperidin and flaxseed

Group Type ACTIVE_COMPARATOR

Dietary Supplement: hesperidin and flaxseed

Intervention Type DIETARY_SUPPLEMENT

2 capsules hesperidin and 30 g flaxseed

control

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

no supplementation

flaxseed

Group Type ACTIVE_COMPARATOR

Dietary Supplement: flaxseed

Intervention Type DIETARY_SUPPLEMENT

30 g flaxseed

hesperidin

Group Type ACTIVE_COMPARATOR

Dietary Supplement: hesperidin

Intervention Type DIETARY_SUPPLEMENT

2 capsules hesperidin

Interventions

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Dietary Supplement: hesperidin and flaxseed

2 capsules hesperidin and 30 g flaxseed

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: hesperidin

2 capsules hesperidin

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: flaxseed

30 g flaxseed

Intervention Type DIETARY_SUPPLEMENT

control

no supplementation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No