Metabolic SyndromeNCT06466317
Is There Effect of Adding Honey Intake to Free Walking in Metabolic Syndrome Children
A study testing Honey intake with walking exercise and Walking exercise in people with Metabolic Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Honey intake with walking exercise and Walking exercise
- Type of treatment
- 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
- 6 Jun 2024to 1 Oct 2024
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 40 metabolic syndrome children
Who cannot join
- respiratory, cardiac , renal , liver problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahram canadian university
Giza
hagar El-Hadidy, lecturer, hagarhadidy2016@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Honey intake with walking exercise, Walking exercise
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey intake with walking exerciseBehavioural
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 exerciseBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Behavioral: Walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
high density lipoprotein
it is a component of lipid profile
Measured: it will be assessed after 12 weeks
Secondary outcomes (6)
triglycrides
it is a component of lipid profile
Measured: it will be assessed after 12 weeks
body mass index
it will be measured in morning with empty stomach and badder
Measured: it will be assessed after 12 weeks
waist circumference
it will be measured by a tape at the level of umblicus
Measured: it will be assessed after 12 weeks
systolic blood pressure
it will be measured by manual sphygomamnaometer
Measured: it will be assessed after 12 weeks
diastolic blood pressure
it will be measured by manual sphygomamnaometer
Measured: it will be assessed after 12 weeks
fasting blood glucose
it will be measured at morning
Measured: it will be assessed 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 posted20 Jun 2024
- Study start6 Jun 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed El-Hadidy, Ahram Canadian University
- Investigators
- hagar el-hadidy, lecturer, Principal investigator, Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466317
- Sponsor's protocol ID
- P.T -PED-06/2024- 545
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Metabolic Syndrome Components to Adding Honey Consumption to Free Walking Exercise in Children
- ClinicalTrials.gov ID
- NCT06466317
- Acronym / sponsor ID
- P.T -PED-06/2024- 545
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 Jun 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.
Metabolic Syndrome is common in Children and complementary therapies are important in its treatment such exercise and functional food intake including honey.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey intake with walking exercise | Experimental | Behavioral: Honey intake with walking exercise20 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 | Active comparator | Behavioral: Walking exercise20 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 |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 40 metabolic syndrome children
Key exclusion criteria (1 listed)
- respiratory, cardiac , renal , liver problems
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 with walking exercise20 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) | Behavioural | Honey intake with walking exercise |
| Walking exercise20 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) | Behavioural | walking exercise |
Primary outcome
high density lipoprotein
Time frame: it will be assessed after 12 weeks
it is a component of lipid profile
6 secondary outcomes
triglycrides
Time frame: it will be assessed after 12 weeks
body mass index
Time frame: it will be assessed after 12 weeks
waist circumference
Time frame: it will be assessed after 12 weeks
systolic blood pressure
Time frame: it will be assessed after 12 weeks
diastolic blood pressure
Time frame: it will be assessed after 12 weeks
fasting blood glucose
Time frame: it will be assessed 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 20 Jun 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.
hagar el-hadidy, lecturer principal investigator
Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
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 with walking exercise and Walking exercise in people with Metabolic Syndrome, run by Ahram Canadian 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 1 inclusion and 1 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 20 Jun 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 hagar el-hadidy, lecturer (020 100 745 3552, hagarhadidy2016@gmail.com), 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 20 Jun 2024.