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Metabolic Effects of Honey in Type 1 Diabetes Mellitus

NCT01554566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-03-15

No results posted yet for this study

Summary

This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks intervention periods) was used to measure honey effects. The subjects were randomized into two groups (intervention to control \[I/C\] and control to intervention \[C/I\] groups. Each group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

honey

The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mamdouh AM Abdulrhman, professor · pediatric department, faculty of medicine, ain shams university

  • Mohamed H El Hefnawy, professor · national institute of diabetes and endocrinology, cairo, egypt

  • Rasha H Aly, assist. prof · pediatric department, faculty of medicine, ain shams university

  • Rania H Shatla, lecturer · pediatric department, faculty of medicine, ain shams university

  • Doaa M Mohamed, M.B.B.Ch · pediatric department, faculty of medicine, ain shams university

  • Waheed S Mohamed, M.B.B.Ch · pediatric department, faculty of medicine, ain shams university

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-06-30
Completion
2011-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554566 on ClinicalTrials.gov