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Metabolic Effects of Honey in Type 1 Diabetes Mellitus

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01554566
Enrollment
20
Registered
2012-03-15
Start date
2010-01-31
Completion date
2011-10-31
Last updated
2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

honey, diabetes, lipids, c-peptide

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).

Interventions

DIETARY_SUPPLEMENThoney

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

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
serum lipids12 wkFasting 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

MeasureTime frameDescription
C-peptide12 weekFasting and 2 hr postprandial C-peptide were measured at base line, cross over (12 wk) and end point of the study (24 wk)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026