Clinical trial NCT02488018: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperglycemia, Postprandial
Keywords: Glycemic index
honey
reference glucose
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects
timeFrame: 36 days (9 tests in 4 days interval)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Addis Ababa University
name: Abera Belay, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science and Technology, Botswana College of Agriculture, University of Botswana.
name: Gulelat Haki, Professor
role: STUDY_CHAIR
affiliation: Addis Ababa University
name: Kaleab Baye, Asst Prof.
role: STUDY_CHAIR
affiliation: Columbus State University
name: Samuel Melaku, Assoc Prof.
role: STUDY_CHAIR
References: