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

• ClinicalTrials.gov Identifier: NCT03551613
• Recruitment Status: Completed
• First Posted: June 11, 2018
• Last Update Posted: June 11, 2018
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): yasmin gamal el gendy, Ain Shams University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Malnourished Infants and Childern	Dietary Supplement: honey supplementation	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
• Actual Study Start Date: December 12, 2016
• Actual Primary Completion Date: November 12, 2017
• Actual Study Completion Date: February 25, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: honey group; malnourished children supplemented with honey in dose of 2ml/kg	Dietary Supplement: honey supplementation; honey supplementation
Placebo Comparator: malnourished control group; no honey supplementation only nutrition rehabilitation	Dietary Supplement: honey supplementation; honey supplementation
No Intervention: healthy children; healthy children with no suplementation

Outcome Measures

Primary Outcome Measures :

1. serum leptin [ Time Frame: 2 month duration of honey supplementation ]
   effect of honey supplement on serum leptin in malnourished patients
2. anthropometric measurements [ Time Frame: 2 month duration of honey supplementation ]
   effect of honey on growth assessed by anthropomerty

Secondary Outcome Measures :

1. frequency of infection and total caloric intake in the honey group [ Time Frame: 2 month duration of honey supplementation ]
   compare effect of honey on frequency of infection in supplemented group compared to malnourished on rehabilitation

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 .

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: yasmin gamal el gendy, Lecturer of Pediatrics, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03551613
• Other Study ID Numbers: 6879990
• First Posted: June 11, 2018
• Last Update Posted: June 11, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders