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

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03734510
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 11.1
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Dietary Supplement: Dietary Supplement: hesperidin and flaxseed; Dietary Supplement: Dietary Supplement: hesperidin; Dietary Supplement: Dietary Supplement: flaxseed; Other: control	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effects of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together 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: Mar 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hesperidin and flaxseed	Dietary Supplement: Dietary Supplement: hesperidin and flaxseed; 2 capsules hesperidin and 30 g flaxseed
Placebo Comparator: control	Other: control; no supplementation
Active Comparator: flaxseed	Dietary Supplement: Dietary Supplement: flaxseed; 30 g flaxseed
Active Comparator: hesperidin	Dietary Supplement: Dietary Supplement: hesperidin; 2 capsules hesperidin

Outcome Measures

Primary Outcome Measures

1. liver fibrosis [12 weeks]

   assess by fibroscan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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, MD, PhD, National Nutrition and Food Technology Institute
• ClinicalTrials.gov Identifier: NCT03734510
• Other Study ID Numbers: 13679
• First Posted: Nov 8, 2018
• Last Update Posted: Nov 8, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Nov 8, 2018