Investigation of the Glycemic Index of Ethiopian Honey

Early Phase 1

Completed

• Conditions: Hyperglycemia, Postprandial
• Interventions: Biological: Provision of experimental honey

• Registration Number: NCT02488018
• Lead Sponsor: Addis Ababa University

Brief Summary

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

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-27
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Primary Completion: 2015-11
• Results First Submitted: 2015-11-14
• Study Completion: 2016-02
• Status Verified: 2016-07
• Results First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Results First Posted: 2016-12-28
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Provision of experimental honeys	Provision of experimental honey	Eight experimental monofloral honeys and reference glucose

Primary Outcome Measures

Name	Time	Method
Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects	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).