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

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ClinicalTrials.gov Identifier: NCT03734510
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : February 1, 2019


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




Primary Outcome Measures :
  1. liver fibrosis [ Time Frame: 12 weeks ]
    assess by fibroscan



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734510


Contacts
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Contact: azita Hekmatdoost, MD.PhD +982122357484 a_hekmat2000@yahoo.com

Locations
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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of, 1981619573
Contact: Azits Hekmatdoost, MD,PhD    +982122357484      
Sponsors and Collaborators
National Nutrition and Food Technology Institute

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Responsible Party: Dr Azita Hekmatdoost, MD, PhD, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03734510     History of Changes
Other Study ID Numbers: 13679
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases