Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake

NCT ID: NCT06596109

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-02-15

Brief Summary

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honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated

Detailed Description

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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.

Conditions

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Fatty Liver, Nonalcoholic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

honey intake and lifestyle changes

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

lifestyle changes

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali MA Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali MA Isamil, Lecturer

Role: CONTACT

0201005154209

Alshaymaa S Abd El-Azeim, Lecturer

Role: CONTACT

021033771553

Facility Contacts

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Ali Ismail, lecturer

Role: primary

+201005154209

Alshaymaa S Abd El-Azeim, lecturer

Role: backup

021033771553

Other Identifiers

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P.T.REC/012/005163

Identifier Type: -

Identifier Source: org_study_id

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