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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
Addis Ababa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperglycemia, Postprandial focused on measuring Glycemic index, honey, reference glucose

Eligibility Criteria

20 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 27, 2015
    Last Updated
    November 2, 2016
    Sponsor
    Addis Ababa University
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    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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