Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake

September 11, 2024 updated by: Ali Mohamed Ali ismail, Cairo University
honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty fatty liver (non-alcoholic from) patients with obesity are included to be divided into group 1 who will contain 20 patients who will receive honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks. Group 2 who will contain 20 patients who will receive low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ali MA Ismail, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • fatty liver (non alcoholic form)
  • both sexes included
  • obese subjects (class I)

Exclusion Criteria:

  • cardiac insult
  • respiratory insult
  • renal insult
  • lower limb insult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: honey intake and lifestyle changes
Twenty fatty liver (non-alcoholic from) patients with obesity are included as 20 patients who will receive honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.
Behavioral: honey intake and lifestyle changes
Twenty fatty liver (non-alcoholic from) patients with obesity are included as 20 patients who will receive natural unprocessed honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.
Active Comparator: lifestyle changes
Twenty fatty liver (non-alcoholic from) patients with obesity are included as 20 patients who will receive low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.
Behavioral: lifestyle changes
Twenty fatty liver (non-alcoholic from) patients with obesity are included as 20 patients who will receive low calorie diet and treadmill walking (40 minutes per session, three times per week) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High density lipoprotein
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
triglycerides
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks
cholesterol
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks
low density lipoprotein
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks
alanine transamianse
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks
aspartate transamianse
Time Frame: it will be assessed after 12 weeks
it will be measured in serum
it will be assessed after 12 weeks
fasting blood glucose
Time Frame: it will be measured after 12 weeks
it will be measured in serum
it will be measured after 12 weeks
body mass index
Time Frame: it will be measured after 12 weeks
it will be measured on empty stomach
it will be measured after 12 weeks
waist circumference
Time Frame: it will be measured after 12 weeks
it will be measured on empty stomach
it will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, lecturer, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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