NCT03734510

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement: hesperidin and flaxseed	2 capsules hesperidin and 30 g flaxseed
DIETARY_SUPPLEMENT	Dietary Supplement: hesperidin	2 capsules hesperidin
DIETARY_SUPPLEMENT	Dietary Supplement: flaxseed	30 g flaxseed
OTHER	control	no supplementation

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2018-11-08
• Last updated: 2018-11-08

Locations

1 site across 1 country: Iran