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Recruiting

NCT Number: NCT06596109

Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake

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

Recruiting

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Ali Ismail, lecturer

CONTACT

[email protected]

+201005154209

Ali MA Ismail, Lecturer

PRINCIPAL_INVESTIGATOR

Alshaymaa S Abd El-Azeim, lecturer

CONTACT

[email protected]

021033771553

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

honey intake and lifestyle changes

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

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.

Primary outcomes

  1. High density lipoprotein

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

Secondary outcomes

  1. triglycerides

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

  2. cholesterol

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

  3. low density lipoprotein

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

  4. alanine transamianse

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

  5. aspartate transamianse

    Time frame: it will be assessed after 12 weeks

    it will be measured in serum

  6. fasting blood glucose

    Time frame: it will be measured after 12 weeks

    it will be measured in serum

  7. body mass index

    Time frame: it will be measured after 12 weeks

    it will be measured on empty stomach

  8. waist circumference

    Time frame: it will be measured after 12 weeks

    it will be measured on empty stomach

Study contacts

Contact information is provided by the study sponsor or research team.

Ali MA Isamil, Lecturer

CONTACT

[email protected]

0201005154209

Alshaymaa S Abd El-Azeim, Lecturer

CONTACT

[email protected]

021033771553

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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