Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Phase 2

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: honey

• Registration Number: NCT01554566
• Lead Sponsor: Ain Shams University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2012-03
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Study First Posted: 2012-03-15
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
honey, no honey	honey	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

National Institute of Diabetes and Endocrinology; 🇪🇬 Cairo, Kasr El Ainy, Egypt