Fatty Liver, NonalcoholicNCT06596109
Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake
A study testing honey intake and lifestyle changes and lifestyle changes in people with Fatty Liver, Nonalcoholic, run by Cairo University at 1 site in Egypt.
Trial summary
honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- What is being tested?
- honey intake and lifestyle changes and lifestyle changes
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- fatty liver (non alcoholic form)
- both sexes included
- obese subjects (class I)
Who cannot join
- cardiac insult
- respiratory insult
- renal insult
- lower limb insult
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
Alshaymaa S Abd El-Azeim, lecturer, 021033771553, Shimaashaaban30@yahoo.com
About this study
honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated
Read the 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.
- Conditions
- Fatty Liver, Nonalcoholic
- Being tested
- honey intake and lifestyle changes, lifestyle changes
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honey intake and lifestyle changesBehavioural
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 changesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
High density lipoprotein
it will be measured in serum
Measured: it will be assessed after 12 weeks
Secondary outcomes (8)
triglycerides
it will be measured in serum
Measured: it will be assessed after 12 weeks
cholesterol
it will be measured in serum
Measured: it will be assessed after 12 weeks
low density lipoprotein
it will be measured in serum
Measured: it will be assessed after 12 weeks
alanine transamianse
it will be measured in serum
Measured: it will be assessed after 12 weeks
aspartate transamianse
it will be measured in serum
Measured: it will be assessed after 12 weeks
fasting blood glucose
it will be measured in serum
Measured: it will be measured after 12 weeks
body mass index
it will be measured on empty stomach
Measured: it will be measured after 12 weeks
waist circumference
it will be measured on empty stomach
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596109
- Sponsor's protocol ID
- P.T.REC/012/005163
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake
- ClinicalTrials.gov ID
- NCT06596109
- Acronym / sponsor ID
- P.T.REC/012/005163
- Conditions
- Fatty Liver, Nonalcoholic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| honey intake and lifestyle changes | Experimental | Behavioral: honey intake and lifestyle changesTwenty 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. |
| lifestyle changes | Active comparator | Behavioral: lifestyle changesTwenty 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- fatty liver (non alcoholic form)
- both sexes included
- obese subjects (class I)
Key exclusion criteria (4 listed)
- cardiac insult
- respiratory insult
- renal insult
- lower limb insult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honey intake and lifestyle changesTwenty 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. | Behavioural | honey intake and lifestyle changes |
| lifestyle changesTwenty 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. | Behavioural | lifestyle changes |
Primary outcome
High density lipoprotein
Time frame: it will be assessed after 12 weeks
it will be measured in serum
8 secondary outcomes
triglycerides
Time frame: it will be assessed after 12 weeks
cholesterol
Time frame: it will be assessed after 12 weeks
low density lipoprotein
Time frame: it will be assessed after 12 weeks
alanine transamianse
Time frame: it will be assessed after 12 weeks
aspartate transamianse
Time frame: it will be assessed after 12 weeks
fasting blood glucose
Time frame: it will be measured after 12 weeks
body mass index
Time frame: it will be measured after 12 weeks
waist circumference
Time frame: it will be measured after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing honey intake and lifestyle changes and lifestyle changes in people with Fatty Liver, Nonalcoholic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High density lipoprotein (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.