Investigation of the Glycemic Index of Ethiopian Honey

Hyperglycemia, Postprandial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02488018
• Other study ID #: Honey-1
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: June 27, 2015
• Last updated: June 30, 2015
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Addis Ababa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

The 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 different honeys will be used as experimental foods. To determine the GI value, a portion of food containing 25 grams of available carbohydrate will be fed for ten healthy people in the morning after they have fasted for 11 hours overnight. After fasting blood sample will be obtained. The study participants will be consumed all honey or reference glucose served. Additional blood samples will be taken at 15, 30, 45, 60, 90 and 120 minutes after eating commenced. The two-hour blood glucose response for test food will be compared to the two-hour blood glucose response produced by pure glucose sugar. Glucose concentration in the seven blood samples was used to graph a two-hour blood glucose response curve. The area under two-hour blood plasma glucose response curve (AUC) for reference and test food was calculated by the trapezoidal rule and ANOVA (Analysis of Variance), using SAS (Statistical Analysis Software), 2002.

GI= AUCt/AUCr*100

Where:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 24 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia, Postprandial

Intervention

Other:
• Honey Glycemic Index
25g available carbohydrate provide for each subject after taking fasting blood glucose level, and blood samples will be taken with an interval of 15minuts for 2hr.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Addis Ababa University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level		Six months	No