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

NCT03734510 | Unknown

• 1 other identifier: 13679
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• liver fibrosis

  assess by fibroscan

  12 weeks

Study Arms (4)

hesperidin and flaxseed

ACTIVE COMPARATOR

Dietary Supplement: Dietary Supplement: hesperidin and flaxseed

control

PLACEBO COMPARATOR

Other: control

flaxseed

ACTIVE COMPARATOR

Dietary Supplement: Dietary Supplement: flaxseed

hesperidin

ACTIVE COMPARATOR

Dietary Supplement: Dietary Supplement: hesperidin

Interventions

Dietary Supplement: hesperidin and flaxseed DIETARY_SUPPLEMENT

2 capsules hesperidin and 30 g flaxseed

hesperidin and flaxseed

Dietary Supplement: hesperidin DIETARY_SUPPLEMENT

2 capsules hesperidin

hesperidin

Dietary Supplement: flaxseed DIETARY_SUPPLEMENT

30 g flaxseed

flaxseed

control OTHER

no supplementation

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran (the Islamic Republic Of), 1981619573, Iran

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Central Study Contacts

azita Hekmatdoost, MD.PhD

CONTACT

+982122357484; a_hekmat2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: March 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

IR (1)