NCT02488018

Brief Summary

The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise the blood glucose level.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for early_phase_1

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

June 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 28, 2016

Completed
Last Updated

December 28, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

June 27, 2015

Results QC Date

November 14, 2015

Last Update Submit

November 2, 2016

Conditions

Keywords

Glycemic indexhoneyreference glucose

Outcome Measures

Primary Outcomes (1)

  • Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects

    Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose\*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).

    36 days (9 tests in 4 days interval)

Study Arms (1)

Provision of experimental honeys

EXPERIMENTAL

Eight experimental monofloral honeys and reference glucose

Biological: Provision of experimental honey

Interventions

Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense and reference glucose were used as test food. 25g available carbohydrate of the test food was provided to ten human subjects after fasted for 11 hours overnight.

Also known as: Honey Glycemic Index
Provision of experimental honeys

Eligibility Criteria

Age20 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of diabetes Disease
  • Must be able to drink the honeys and reference glucose

You may not qualify if:

  • Overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Abera Belay (PhD Candidate)
Organization
Addis Ababa University [Office telephone +251011-655-1927]

Study Officials

  • Abera Belay, PhDCandidate

    Addis Ababa University

    PRINCIPAL INVESTIGATOR
  • Gulelat Haki, Professor

    Department of Food Science and Technology, Botswana College of Agriculture, University of Botswana.

    STUDY CHAIR
  • Kaleab Baye, Asst Prof.

    Addis Ababa University

    STUDY CHAIR
  • Samuel Melaku, Assoc Prof.

    Columbus State University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 27, 2015

First Posted

July 2, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

December 28, 2016

Results First Posted

December 28, 2016

Record last verified: 2016-07