Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children

Study Overview
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Brief Summary
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This study was a randomized single blinded case control prospective intervention study.

Detailed Description
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Fifty infants and children of both sexes, aged 6 months to 3 years, with malnutrition were consecutively recruited from the Nutrition Clinic of the Pediatric Hospital, Ain Shams University. These patients were randomly assigned following a simple randomization procedure (computerized random numbers) to either the honey group (group 1) or the malnourished control group (group 2) with a 1:1 allocation ratio. Each group consisted of 25 patients. An additional 25 healthy infants and children with the same age range and of both sexes were recruited from the outpatient pediatric clinic of Ain Shams University, Egypt as a healthy control group (group 3). The inclusion criteria was in whom the under nutrition is caused by inadequate energy intake, while the exclusion criteria included markedly ill patients, and children with chronic or severe systemic illness or malabsorption disorders, chromosomal aberrations, inborn errors of metabolism and cerebral palsy. History taking with special emphasis on the dietetic history, history of any disease that might interfere with the nutrient intake or their use by the body and history of any acute or chronic illness. And full body Examination which include anthropometric measurements weight, height and mid arm circumference. Each patient in the intervention group or honey group or group 1 took oral honey in a dose of 2ml/kg/day for 8 weeks; the calculated dose of honey was dissolved in water with a ratio of 1: 3, respectively, and then ingested by the patient before breakfast.

Official Title
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Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children

Conditions
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Malnourished Infants and Childern

Intervention / Treatment
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* Dietary Supplement: honey supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: simple malnutrition Exclusion Criteria: cancer, sepsis, endocrine disorders, neurologic disorders, diabetes mellitus, heart failure renal failure liver cell failure. malabsorption disorders, chromosomal aberrations, inborn errors of metabolism cerebral palsy .

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: honey group<br>malnourished children supplemented with honey in dose of 2ml/kg | Dietary Supplement: honey supplementation<br>* honey supplementation<br>|
| Placebo Comparator: malnourished control group<br>no honey supplementation only nutrition rehabilitation | Dietary Supplement: honey supplementation<br>* honey supplementation<br>|
| No Intervention: healthy children<br>healthy children with no suplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum leptin | effect of honey supplement on serum leptin in malnourished patients | 2 month duration of honey supplementation | 
| anthropometric measurements | effect of honey on growth assessed by anthropomerty | 2 month duration of honey supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of infection and total caloric intake in the honey group | compare effect of honey on frequency of infection in supplemented group compared to malnourished on rehabilitation | 2 month duration of honey supplementation |