Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554566
• Other study ID #: honey1010
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2012
• Last updated: March 14, 2012
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
Egypt	National Institute of Diabetes and Endocrinology	Cairo	Kasr El Ainy

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum lipids	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)	12 wk	Yes
Secondary	C-peptide	Fasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)	12 week	Yes

External Links

•   Faculty of medicine, Ain Shams University, Egypt