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

Ain Shams University

Status: Completed

Conditions: Malnourished Infants and Childern

Treatments: Dietary Supplement: honey supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03551613

6879990

Details and patient eligibility

About

This study was a randomized single blinded case control prospective intervention study.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups, including a placebo group

honey group

Active Comparator group

Description:

malnourished children supplemented with honey in dose of 2ml/kg

Treatment:

Dietary Supplement: honey supplementation

malnourished control group

Placebo Comparator group

Description:

no honey supplementation only nutrition rehabilitation

Treatment:

Dietary Supplement: honey supplementation

healthy children

No Intervention group

Description:

healthy children with no suplementation