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

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Non Alcoholic Steatohepatitis

Treatments: Dietary Supplement: Dietary Supplement: flaxseed; Dietary Supplement: Dietary Supplement: hesperidin; Dietary Supplement: Dietary Supplement: hesperidin and flaxseed; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT03734510

13679

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups, including a placebo group

hesperidin and flaxseed

Active Comparator group

Treatment:

Dietary Supplement: Dietary Supplement: hesperidin and flaxseed

control

Placebo Comparator group

Treatment:

Other: control

flaxseed

Active Comparator group

Treatment:

Dietary Supplement: Dietary Supplement: flaxseed

hesperidin

Active Comparator group

Treatment:

Dietary Supplement: Dietary Supplement: hesperidin