NCT06596109

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 11, 2024

Last Update Submit

September 11, 2024

Conditions

Fatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

  • High density lipoprotein

    it will be measured in serum

    it will be assessed after 12 weeks

Secondary Outcomes (8)

  • triglycerides

    it will be assessed after 12 weeks

  • cholesterol

    it will be assessed after 12 weeks

  • low density lipoprotein

    it will be assessed after 12 weeks

  • alanine transamianse

    it will be assessed after 12 weeks

  • aspartate transamianse

    it will be assessed after 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

honey intake and lifestyle changes

EXPERIMENTAL

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

lifestyle changes

ACTIVE COMPARATOR

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

Interventions

honey intake and lifestyle changesBEHAVIORAL

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.

honey intake and lifestyle changes
lifestyle changesBEHAVIORAL

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.

lifestyle changes

Eligibility Criteria

Age30 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Isamil, Lecturer

CONTACT

0201005154209ali.mohamed@pt.cu.edu.eg

Alshaymaa S Abd El-Azeim, Lecturer

CONTACT

021033771553Shimaashaaban30@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

September 10, 2024

Primary Completion

January 30, 2025

Study Completion

February 15, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(1)