Investigation of the Glycemic Index of Ethiopian Honey

NCT ID: NCT02488018

Last Updated: 2016-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise the blood glucose level.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia, Postprandial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Glycemic index honey reference glucose

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Provision of experimental honeys

Eight experimental monofloral honeys and reference glucose

Group Type EXPERIMENTAL

Provision of experimental honey

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Provision of experimental honey

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.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Honey Glycemic Index

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Addis Ababa University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abera Belay

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abera Belay, PhDCandidate

Role: PRINCIPAL_INVESTIGATOR

Addis Ababa University

Gulelat Haki, Professor

Role: STUDY_CHAIR

Department of Food Science and Technology, Botswana College of Agriculture, University of Botswana.

Kaleab Baye, Asst Prof.

Role: STUDY_CHAIR

Addis Ababa University

Samuel Melaku, Assoc Prof.

Role: STUDY_CHAIR

Columbus State University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Honey-1

Identifier Type: -

Identifier Source: org_study_id