Metabolic Effects of Honey in Type 1 Diabetes Mellitus

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Dietary Supplement: honey

Study type: Interventional

Funder types: Other

Identifiers

NCT01554566

honey1010

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

honey, no honey

Experimental group

Treatment:

Dietary Supplement: honey