- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02488018
Investigation of the Glycemic Index of Ethiopian Honey
Investigation of Ethiopian Honey: Botanical Origin, Physicochemical, Antioxidant, Microbial Quality, Glycemic Index and Sensory Properties
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Honey-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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