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

Malnourished Infants and Childern Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551613
• Other study ID #: 6879990
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: February 25, 2018

Study information

• Verified date: May 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 25, 2018
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Malnourished Infants and Childern
• Malnutrition

Intervention

Dietary Supplement:
• honey supplementation
honey supplementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum leptin	effect of honey supplement on serum leptin in malnourished patients	2 month duration of honey supplementation
Primary	anthropometric measurements	effect of honey on growth assessed by anthropomerty	2 month duration of honey supplementation
Secondary	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