Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT01554566

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Dietary Supplement: honey	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Metabolic Effects of Honey in Type 1 Diabetes Mellitus: a Cross Over Randomised Controlled Pilot Study

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: honey, no honey	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). Other Names: bee honey

Arm

Intervention/Treatment

Experimental: honey, no honey

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).

Other Names:

bee honey

Outcome Measures

Primary Outcome Measures

serum lipids [12 wk]
Fasting serum lipids (cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol) were measured at base line, cross over (12 wk) and end point of the study (24 wk)

Secondary Outcome Measures

C-peptide [12 week]
Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with type 1 diabetes mellitus with their last HbA1C less than 10% were candidates for this study.

Exclusion Criteria:

Coexisting renal or hepatic impairment
Coexisting diseases e.g., malignancy, other endocrine disorders
Patients on steroid therapy or other drugs that may affect the body weight or serum lipids.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Diabetes and Endocrinology	Cairo	Kasr El Ainy	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mamdouh AM Abdulrhman, professor, pediatric department, faculty of medicine, ain shams university
Principal Investigator: Mohamed H El Hefnawy, professor, national institute of diabetes and endocrinology, cairo, egypt
Principal Investigator: Rasha H Aly, assist. prof, pediatric department, faculty of medicine, ain shams university
Principal Investigator: Rania H Shatla, lecturer, pediatric department, faculty of medicine, ain shams university
Principal Investigator: Doaa M Mohamed, M.B.B.Ch, pediatric department, faculty of medicine, ain shams university
Principal Investigator: Waheed S Mohamed, M.B.B.Ch, pediatric department, faculty of medicine, ain shams university