Investigation of the Glycemic Index of Ethiopian Honey
Primary Purpose
Hyperglycemia, Postprandial
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Provision of experimental honey
Sponsored by
About this trial
This is an interventional supportive care trial for Hyperglycemia, Postprandial focused on measuring Glycemic index, honey, reference glucose
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Provision of experimental honeys
Arm Description
Eight experimental monofloral honeys and reference glucose
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02488018
Brief Title
Investigation of the Glycemic Index of Ethiopian Honey
Official Title
Investigation of Ethiopian Honey: Botanical Origin, Physicochemical, Antioxidant, Microbial Quality, Glycemic Index and Sensory Properties
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Addis Ababa University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Postprandial
Keywords
Glycemic index, honey, reference glucose
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Provision of experimental honeys
Arm Type
Experimental
Arm Description
Eight experimental monofloral honeys and reference glucose
Intervention Type
Biological
Intervention Name(s)
Provision of experimental honey
Other Intervention Name(s)
Honey Glycemic Index
Intervention Description
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.
Primary Outcome Measure Information:
Title
Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Description
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).
Time Frame
36 days (9 tests in 4 days interval)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abera Belay, PhDCandidate
Organizational Affiliation
Addis Ababa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gulelat Haki, Professor
Organizational Affiliation
Department of Food Science and Technology, Botswana College of Agriculture, University of Botswana.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kaleab Baye, Asst Prof.
Organizational Affiliation
Addis Ababa University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Samuel Melaku, Assoc Prof.
Organizational Affiliation
Columbus State University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Due to the Ethical issue, sharing data to 3rd party is not decided yet.
Learn more about this trial
Investigation of the Glycemic Index of Ethiopian Honey
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