Investigation of the Glycemic Index of Ethiopian Honey

November 2, 2016 updated by: Abera Belay, Addis Ababa University

Investigation of Ethiopian Honey: Botanical Origin, Physicochemical, Antioxidant, Microbial Quality, Glycemic Index and Sensory Properties

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

Study Overview

Status

Completed

Detailed Description

Addis Ababa University, College of Natural Sciences, Research Institutional Review Board (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7 females and 7 males). The subjects were randomly recruited from twenty eight 3rd year Food Science and Postharvest Technology students. People volunteering to participate in the study were excluded if they are: overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication. The participants were checked for glucose tolerance according to the WHO (World Health Organization) classification (fasting glucose <7 mmol/L(millimole per lite) and 2-hour blood glucose concentration after a 25g glucose load <7.8 mmol/L). Ten (5 females and 5 males) were selected from fourteen using lottery sampling methods. Reference glucose and monofloral honeys were used as experimental foods. To determine the GI value, 25 grams of available carbohydrate was fed for ten healthy people in the morning after they have fasted for 11 hours overnight. After fasting blood sample was obtained. The study participants were consumed each honey and reference glucose served. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes after eating commenced. Blood glucose response (Area under the curve, AUCt) for test food was compared to the blood glucose response of reference glucose (AUCr). AUC was calculated using SAS (Statistical Analysis Software), 2002. Glycemic index (GI) was calculated using:

GI= AUCt/AUCr*100

Where:

AUCt = Area Under the Curve for honey; AUCr = Area Under the Curve for the reference glucose

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provision of experimental honeys
Eight experimental monofloral honeys and reference glucose

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.

Other Names:
  • Honey Glycemic Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Time Frame: 36 days (9 tests in 4 days interval)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Abera Belay, PhDCandidate, Addis Ababa University
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 27, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Honey-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to the Ethical issue, sharing data to 3rd party is not decided yet.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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