- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466317
Is There Effect of Adding Honey Intake to Free Walking in Metabolic Syndrome Children
June 14, 2024 updated by: Hagar Ahmed El-Hadidy, Ahram Canadian University
Response of Metabolic Syndrome Components to Adding Honey Consumption to Free Walking Exercise in Children
Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Forty Children with metabolic syndrome will Assigned to group of free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking was supervised by authors via Videoconferencing Imo Program) and this group also will receive healthy dietary guidelines in addition to consuming natural honey for 12 weeks..
The other group that will contain 20 patients will take only free walking exercise and healthy diet guidelines 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
- Name: hagar el-hadidy, lecturer
- Phone Number: 020 100 745 3552
- Email: hagarhadidy2016@gmail.com
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- Ahram Canadian University
-
Contact:
- hagar El-Hadidy, lecturer
- Email: hagarhadidy2016@gmail.com
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 40 metabolic syndrome children
Exclusion Criteria:
- respiratory, cardiac , renal , liver problems
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 with walking exercise
20 Children with metabolic syndrome will receive free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking will supervised by authors via Videoconferencing Imo Program) and this group also will healthy diet guidelines in addition to consuming natural honey (2ml/kg honey will be taken..
This dose will be divided into two halves, the first half will be taken at 7 am and the other half will be taken at 7 pm for 12 weeks)
|
20 Children with metabolic syndrome will receive free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking will supervised by authors via Videoconferencing Imo Program) and this group also will healthy diet guidelines in addition to consuming natural honey (2ml/kg honey will be taken..
This dose will be divided into two halves, the first half will be taken at 7 am and the other half will be taken at 7 pm for 12 weeks)
|
|
Active Comparator: walking exercise
20 Children with metabolic syndrome will receive free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking will supervised by authors via Videoconferencing Imo Program) and this group also will healthy diet guidelines for 12 weeks
|
20 Children with metabolic syndrome will receive free walking continuous exercise (thirty minutes daily in nearby sport club in the presence of their parents and walking will supervised by authors via Videoconferencing Imo Program) and this group also will healthy diet guidelines 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 is a component of lipid profile
|
it will be assessed after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
triglycrides
Time Frame: it will be assessed after 12 weeks
|
it is a component of lipid profile
|
it will be assessed after 12 weeks
|
|
body mass index
Time Frame: it will be assessed after 12 weeks
|
it will be measured in morning with empty stomach and badder
|
it will be assessed after 12 weeks
|
|
waist circumference
Time Frame: it will be assessed after 12 weeks
|
it will be measured by a tape at the level of umblicus
|
it will be assessed after 12 weeks
|
|
systolic blood pressure
Time Frame: it will be assessed after 12 weeks
|
it will be measured by manual sphygomamnaometer
|
it will be assessed after 12 weeks
|
|
diastolic blood pressure
Time Frame: it will be assessed after 12 weeks
|
it will be measured by manual sphygomamnaometer
|
it will be assessed after 12 weeks
|
|
fasting blood glucose
Time Frame: it will be assessed after 12 weeks
|
it will be measured at morning
|
it will be assessed after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hagar el-hadidy, lecturer, Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
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)
June 6, 2024
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
June 14, 2024
First Submitted That Met QC Criteria
June 14, 2024
First Posted (Actual)
June 20, 2024
Study Record Updates
Last Update Posted (Actual)
June 20, 2024
Last Update Submitted That Met QC Criteria
June 14, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T -PED-06/2024- 545
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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