NCT06466317

Brief Summary

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

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 Jun 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

June 6, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 14, 2024

Last Update Submit

June 14, 2024

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • high density lipoprotein

    it is a component of lipid profile

    it will be assessed after 12 weeks

Secondary Outcomes (6)

  • triglycrides

    it will be assessed after 12 weeks

  • body mass index

    it will be assessed after 12 weeks

  • waist circumference

    it will be assessed after 12 weeks

  • systolic blood pressure

    it will be assessed after 12 weeks

  • diastolic blood pressure

    it will be assessed after 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Honey intake with walking exercise

EXPERIMENTAL

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)

Behavioral: Honey intake with walking exercise

walking exercise

ACTIVE COMPARATOR

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

Behavioral: Walking exercise

Interventions

Honey intake with walking exerciseBEHAVIORAL

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)

Honey intake with walking exercise
Walking exerciseBEHAVIORAL

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)

walking exercise

Eligibility Criteria

Age9 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • metabolic syndrome children

You may not qualify if:

  • respiratory, cardiac , renal , liver problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahram canadian university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • hagar el-hadidy, lecturer

    Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hagar el-hadidy, lecturer

CONTACT

020 100 745 3552hagarhadidy2016@gmail.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
Lecturer of Physical Therapy for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

June 6, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

EG(1)