NCT03734510

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

Status unknown NA Last updated 8 November 2018

What this trial tests

NA trial testing Dietary Supplement: hesperidin and flaxseed in Non Alcoholic Steatohepatitis in 100 participants. Status unknown.

Timeline

1 March 2018

Primary endpoint
1 January 2019

1 February 2019

Quick facts

Lead sponsor	National Nutrition and Food Technology Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 March 2018
Primary completion	1 January 2019
Estimated completion	1 February 2019
Sites	1 location across Iran

Drugs / interventions tested

• Dietary Supplement: hesperidin and flaxseed
• Dietary Supplement: hesperidin
• Dietary Supplement: flaxseed
• control

Conditions studied

• Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →

Sponsor

National Nutrition and Food Technology Institute

Who can join

Adults 18 to 70, any sex, with Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of dietary polyphenol supplementation in the treatment of non-alcoholic fatty liver disease: A systematic review and meta-analysis.
   Yang K, Chen J, Zhang T, Yuan X, et al · · 2022 · cited 57× · PMID 36159792 · DOI 10.3389/fimmu.2022.949746
2. Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis.
   Komolafe O, Buzzetti E, Linden A, Best LM, et al · · 2021 · cited 12× · PMID 34280304 · DOI 10.1002/14651858.cd013157.pub2
3. Unlocking Cholesterol Metabolism in Metabolic-Associated Steatotic Liver Disease: Molecular Targets and Natural Product Interventions.
   Li X, Li M. · · 2024 · cited 9× · PMID 39204178 · DOI 10.3390/ph17081073
4. Addressing the heterogeneity in liver diseases using biological networks.
   Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002