Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201904874997298 Date of Registration: 18/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Nigerian Honey on Blood Glucose and Lipids in Patients with Diabetes
Official scientific title Effects of Nigerian Honey on Hyperglycemia and Lipid Abnormalities in Patients with Type 2 Diabetes Mellitus
Brief summary describing the background and objectives of the trial Diabetes mellitus is rapidly becoming an epidemic as a result of its increasing global prevalence. The disorder is managed with antidiabetic drugs. Even though these drugs are beneficial to a less extent, the use of these agents is associated with a number of challenges such as inability to achieve glycemic control with a single drug, unaffordability, unavailability, adverse effects and counterfeit problems. These problems have resulted in a renewed interest among patients with diabetes to utilize alternative medicines/complementary medicines. Honey is one of such alternative medicines. Nigerian honey has been reported to exert hypoglycemic, antihyperlipidemic and antioxidant effects in rodent models of diabetes mellitus. However, there are no clinical data on the above-mentioned effects of Nigerian honey. Therefore, the objectives of this study are to investigate the effects of Nigerian honey on blood glucose (BG), total cholesterol (TC), triglycerides (TG), high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, malondialdehyde (MDA) and total antioxidant status (TAS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/05/2019
Actual trial start date
Anticipated date of last follow up 23/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 36
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Honey group 0.5 g/kg body weight of honey to be administered orally once daily before breakfast 4 weeks The participants will receive honey and at the same time continue to take their standard antidiabetic drugs 26
Control Group Control group Not applicable/No dose 4 weeks The participants will not receive honey but will continue to receive their standard antidiabetic drugs 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with fasting blood glucose of >/= 126 mg/dL Patients on a biguanide and a sulphonylurea Willingness to comply with the demands of the experimental protocol Patients who are insulin dependent Patients with malignancy/cancer and other serious underlying disease conditions Patients who are taking certain kinds of medications such as cytotoxic, immunosuppressive, immunomodulatory, stimulating, performance-enhancing drugs Regular consumption of alcohol or supplements (esipecially antioxidant supplements) Cigarette smokers Patients who are pregnant or lactating Patients with renal or hepatic impairment Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/03/2019 Federal Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Enugu-Abakaliki Express Way Abakaliki 480214 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum glucose At baseline - week 0 and At the end of the study - week 4
Primary Outcome Serum total cholesterol At baseline - week 0 and At the end of the study - week 4
Primary Outcome Serum triglycerides At baseline - week 0 and At the end of the study - week 4
Primary Outcome Serum high density lipoprotein cholesterol At baseline - week 0 and At the end of the study - week 4
Primary Outcome Serum low density lipoprotein cholesterol At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Blood pressure At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Serum malondialdehyde At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Serum total antioxidant status At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Serum creatinine At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Serum alanine transaminase At baseline - week 0 and At the end of the study - week 4
Secondary Outcome Body weight At baseline - week 0 and At the end of the study - week 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Enugu-Abakaliki Express Way Abakaliki Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The researchers Department of Pharmacology and Therapeutics, Faculty of Medicine, Ebonyi State University Abakaliki Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ebonyi State University PMB 053, Enugu-Abakaliki Express Way Abakaliki Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Nkemjika Uwaezuoke Department of Pharmacology and Therapeutics, College of Medicine, University of Nigeria Enugu Nigeria
Assoc. Prof. Basil Ezeopko Department of Internal Medicine, Faculty of Medicine, Ebonyi State University Abakaliki Nigeria
Dr. Joseph Akpan Department of Pharmacology, University of Calabar Calabar Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omotayo Erejuwa erejuwa@gmail.com +2348120885193 Department of Pharmacology and Therapeutics, Faculty of Medicine, Ebonyi State University, Enugu-Abakaliki Express Way
City Postal code Country Position/Affiliation
Abakaliki 480214 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Omotayo Erejuwa erejuwa@gmail.com +2348120885193 Department of Pharmacology and Therapeutics, Faculty of Medicine, Ebonyi State University, Enugu-Abakaliki Express Way.
City Postal code Country Position/Affiliation
Abakaliki 480214 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Maria Offor nkeychi4eva@gmail.com +2348066124427 Department of Pharmacology and Therapeutics, Faculty of Medicine, Ebonyi State University, Enugu-Abakaliki Express Way
City Postal code Country Position/Affiliation
Abakaliki 480214 Nigeria Postgraduate Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be provided upon request which should be justified. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6-12 months after completion of the study Closed and subject to approval by Ethics Committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information