NCT01554566

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

March 9, 2012

Last Update Submit

March 14, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

honeydiabeteslipidsc-peptide

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • C-peptide

    12 week

Study Arms (1)

honey, no honey

EXPERIMENTAL
Dietary Supplement: honey

Interventions

honeyDIETARY_SUPPLEMENT

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).

Also known as: bee honey
honey, no honey

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes and Endocrinology

Cairo, Kasr El Ainy, Egypt

Location

Related Publications (1)

  • Abdulrhman MM, El-Hefnawy MH, Aly RH, Shatla RH, Mamdouh RM, Mahmoud DM, Mohamed WS. Metabolic effects of honey in type 1 diabetes mellitus: a randomized crossover pilot study. J Med Food. 2013 Jan;16(1):66-72. doi: 10.1089/jmf.2012.0108. Epub 2012 Dec 20.

    PMID: 23256446DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Honeypteropsin, Apis mellifera

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 15, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

EG(1)