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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06466317
Other study ID # P.T -PED-06/2024- 545
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2024
Est. completion date October 1, 2024

Study information

Verified date June 2024
Source Ahram Canadian University
Contact hagar el-hadidy, lecturer
Phone 020 100 745 3552
Email hagarhadidy2016@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - 40 metabolic syndrome children Exclusion Criteria: - respiratory, cardiac , renal , liver problems

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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)
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)

Locations

Country Name City State
Egypt Ahram canadian university Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary high density lipoprotein it is a component of lipid profile it will be assessed after 12 weeks
Secondary triglycrides it is a component of lipid profile it will be assessed after 12 weeks
Secondary body mass index it will be measured in morning with empty stomach and badder it will be assessed after 12 weeks
Secondary waist circumference it will be measured by a tape at the level of umblicus it will be assessed after 12 weeks
Secondary systolic blood pressure it will be measured by manual sphygomamnaometer it will be assessed after 12 weeks
Secondary diastolic blood pressure it will be measured by manual sphygomamnaometer it will be assessed after 12 weeks
Secondary fasting blood glucose it will be measured at morning it will be assessed after 12 weeks
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