Trial Outcomes & Findings for Investigation of the Glycemic Index of Ethiopian Honey (NCT NCT02488018)
NCT ID: NCT02488018
Last Updated: 2016-12-28
Results Overview
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).
COMPLETED
EARLY_PHASE1
10 participants
36 days (9 tests in 4 days interval)
2016-12-28
Participant Flow
After a through orientation on research objectives to 3rd year Food Science \& Technology students, 14 volunteer free of: overweight, dieting, smoking, family history of diabetes, pregnant, metabolic disorders, and suffering from food allergy were selected. Out of 14 eligible students, 5female and 5male students were selected using lottery sampling.
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).
Participant milestones
| Measure |
Honey Glycemic Index
Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.
Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of the Glycemic Index of Ethiopian Honey
Baseline characteristics by cohort
| Measure |
Provision of Experimental Honeys
n=10 Participants
Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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21.60 years
STANDARD_DEVIATION 1.17 • n=5 Participants
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Gender
Female
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5 Participants
n=5 Participants
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Gender
Male
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5 Participants
n=5 Participants
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Blood glucose level (mmol/L)
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10 Participant
n=5 Participants
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PRIMARY outcome
Timeframe: 36 days (9 tests in 4 days interval)Population: All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.
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).
Outcome measures
| Measure |
Provision of Experimental Honeys
n=10 Participants
Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.
25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Acacia
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54.73 Index
Standard Deviation 7.19
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Becium grandiflorum
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62.82 Index
Standard Deviation 7.73
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Croton macrostachyus
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60.31 Index
Standard Deviation 7.26
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Eucalyptus globulus
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59.54 Index
Standard Deviation 7.34
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Hypoestes
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63.22 Index
Standard Deviation 6.69
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Leucas abyssinica
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64.06 Index
Standard Deviation 7.58
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Schefflera abyssinica
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71.90 Index
Standard Deviation 7.47
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Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
Syzygium guineense
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63.07 Index
Standard Deviation 7.37
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Adverse Events
Honey Glycemic Index
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Abera Belay (PhD Candidate)
Addis Ababa University [Office telephone +251011-655-1927]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place