Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005626842621 Date of Registration: 04/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of moringa oleifera leaves on the blood glucose, blood pressure, lipid profile and haematological parameters of type 2 diabetics in a rural Nigerian community.
Official scientific title Effect of moringa oleifera leaves on the blood glucose, blood pressure, lipid profile and haematological parameters of type 2 diabetics in a rural Nigerian community.
Brief summary describing the background and objectives of the trial According to WHO (1999), diabetes is a metabolic disorder of multiple aetiology characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action or both. Diabetic patients tend to have higher triglyceride, lower high-density lipoprotein cholesterol (HDL) and similar low-density lipoprotein cholesterol (LDL) levels compared with non-diabetic patients (National Cholesterol Education Programme (NCEP), 2001). Sowers, Epstein and Frohlich (2001) noted that diabetes and high blood pressure tend to occur together because they share certain physiological traits – that is, the effects caused by each disease tend to make the other disease more likely to occur. Diabetes increases total amount of fluid in the body and decreases the ability of the blood vessels to stretch thus increasing average blood pressure. Nishizawa and Okuno (1998) observed that erythropoietin synthesis is not increased appropriately when heamoglobin levels fall off in diabetics. Restrictions imposed on the diet of diabetic subjects by non-experts makes it likely for anaemia to occur in these group of persons. Literatures abound where different parts of moringa tree have been used extensively in animal models and humans to demonstrate its antidiabetic, hypotensive, antilipidaemic and haematinic qualities; however, there is scarcity of data on the effect of graded levels of moringa leaves on the blood glucose, blood pressure, lipid profile and haematological parameters in human diabetic subjects. Therefore, the aim of this study was to ascertain the effect of graded levels of moringa oleifera leaves on the blood glucose, blood pressure, lipid profile and haematological parameters of type 2 diabetic subjects.
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 Supportive care
Anticipated trial start date 27/10/2014
Actual trial start date 27/10/2014
Anticipated date of last follow up 14/12/2014
Actual Last follow-up date 30/11/2014
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 24
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 1 This group received their normal diets only, three times per day 14 days The diets were prepared such that each supplies one third of the energy requirement of an adult man with a light activity level (2450 Kcal). The subjects were fed morning and evening and they were allowed to take lunch at home and the record of what was eaten kept. 6 Placebo
Experimental Group Group 2 This group received the same diet as group 1 and then steamed 20 g of moringa oleifera leaves per day. They received 2 meals a day so the moringa leaves were given 10 g per meal. 14 days This group received the same diet as group 1 and then steamed 20 g of moringa oleifera leaves per day. They received 2 meals a day so the moringa leaves were given 10 g per meal. 6
Experimental Group Group 3 In addition to the normal diet common to all the groups, group 3 received 40 g of steamed moringa oleifera leaves which was divided into 20 g per meal. They were also fed twice daily. 14 days In addition to the normal diet common to all the groups, group 3 received 40 g of steamed moringa oleifera leaves which was divided into 20 g per meal. They were also fed twice daily. 6
Experimental Group Group 4 This group received 60 g of steamed moringa oleifera leaves in addition to the normal diets. They were fed twice a day and the moringa leaves were divided into two; 30 g per meal. 14 days This group received 60 g of steamed moringa oleifera leaves in addition to the normal diets. They were fed twice a day and the moringa leaves were divided into two; 30 g per meal. 6
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Type 2 diabetics aged 40 years and above. Type 2 diabetics with no obvious complications such as foot ulcer, blindness and stroke. Type 2 diabetics who were neither pregnant nor breastfeeding. Type 2 diabetics who were not obese. Type 2 diabetics who consented to partake in the study. Type 2 diabetics who were below 40 years of age. Type 2 diabetes with such complications such as foot ulcer, blindness and stroke. Type 2 diabetics who were either pregnant or breastfeeding. Type 2 diabetics who were obese. Type 2 diabetics who did not give their consent to partake in the study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 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 17/06/2013 University of Nigeria Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pot Harcourt - Enugu Express way, Enugu State Enugu 0234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fasting blood glucose. There was a non-significant (p > 0.05) decrease in the mean fasting blood glucose levels of the subjects in group 1 (from 163.67 mg/dl before the feeding to 161.17 mg/dl after the feeding trial). Subjects in group 2 had a non-significant (p > 0.05) increase in their fasting blood glucose level from 146.00 mg/dl before the feeding to 158.00 mg/dl after the feeding. There was a reduction in the fasting blood glucose level of the subjects in group 3 (from 228.33 mg/dl to 225.00 mg/dl); however, the decrease was not significant (p > 0.05). Subjects in group 4 had a non-significant (p > 0.05) increase in their fasting blood glucose levels from 244.00 mg/dl to 265.17 mg/dl before and after the feeding trial respectively. Outcome was measured everyday and at the 15th day i.e. a day succeeding the last day of the feeding trial. The values obtained on the 15th day were compared to the ones measured on the first day.
Primary Outcome Blood pressure. Group 3 subjects had a significant (p < 0.05) reduction in their systolic blood pressure from 130.17 mmHg before the feeding to 115.65 mmHg after the feeding. Similarly, subjects in group 4 also had a significant (p < 0.05) reduction in their systolic blood pressure from 142.88 mmHg before the feeding to 127.00 mmHg after the feeding. There was a non-significant (p > 0.05) reduction in the diastolic blood pressure of the subjects in groups 2, 3 and 4 from 76.33 mmHg, 78.33 mmHg and 84.00 mmHg before the feeding trial to 71.33 mmHg, 72.00 mmHg and 77.00 mmHg after the feeding trial respectively. This was measured every day from the beginning of the trial to the end. The baseline and final values were compared at the end.
Primary Outcome Lipid profile: There was a non-significant (p > 0.05) reduction in the mean total cholesterol level of the subjects in groups 1, 2 and 3. Group 2 and 4 had a non-significant (p > 0.05) increase in their mean serum triglyceride from 63.33 mg/dl to 109.00 mg/dl in group 2 and from 107.00 mg/dl to 112.5 mg/dl in group 4. There was a significant (p < 0.05) decrease in the mean LDL cholesterol levels of the subjects in group 2 from 104.67 mg/dl before the feeding to 55.50 mg/dl after the feeding trial. There were significant (p ≤ 0.05) increases in the mean HDL cholesterol levels of the subjects in group 1, 2, and 4 after the feeding trial. The subjects fasting bloods were drawn for analysis on the first day just before the feeding trial commenced and these analysis were repeated on the 15th day after the feeding trial.
Primary Outcome Haematological parameters: Subjects in group 4 had a significant (p < 0.05) decrease in their mean haemoglobin levels from 12.80 g/dl before the feeding to 11.07 g/dl after the feeding trial. There was a non-significant (p > 0.05) reduction in the mean packed cell volume of the subjects in groups 1, 2 and 3 after the feeding trial. Only the group 4 subjects had a significant (p < 0.05) decrease from in their mean white blood cell count from 4616.67 cells/m3 before the feeding to 3550.00 cells/m3 after the feeding trial. This was also measured just before the feeding commenced and at the end of the feeding trial. The baseline values and the final values were compared as well.
Secondary Outcome Anthropometric measurements. There was a significant (p < 0.05) increase in the mean body mass index (BMI) of the subjects in group 1 after the feeding trial. Subjects in group 3 had a non-significant (p > 0.05) decrease in their mean BMI from 24.45 kg/m2 before the feeding to 24.08 kg/m2 after the feeding. There was a non-significant (p > 0.05) decrease in the mean waist circumference of subjects in groups 2 and 3 from 87.50 cm and 92.17 cm before the feeding to 87.33 cm and 91.17 cm after the feeding trial respectively. Groups 2, 3 and 4 had a non-significant (p > 0.05) decrease in their mean waist hip ratio from 1.02 to 1.01, 1.01 to 1.00 and 1.03 to 1.02 before and after the feeding trial respectively. This was measured just before the feeding trial commenced and on the 15th day after the feeding trial. The two values were then compared.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aroh Medical Clinic Ukehe No 1 Ogbodo/Idoha road Umuofiagu Ukehe Nsukka 0234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Afiaenyi Ifeoma Christiana No 10 C Catherine Rest House Road, Onuiyi Nsukka. Nsukka 0234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifeoma Christiana Afiaenyi No 10 C Cathering Rest House Road Onuiyi, Nsukka. Nsukka 0234 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Elizabeth Kanayo Ngwu No 35 Umunkanka Street, University of Nigeria, Nsukka. Nsukka 0234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoma Afiaenyi ifeoma.nwachi@unn.edu.ng +23408061128753 No 10 C Catherine Rest House Road, Onuiyi Nsukka.
City Postal code Country Position/Affiliation
Nsukka 0234 Nigeria Lecturer 1 University of Nigeria Nsukka.
Role Name Email Phone Street address
Public Enquiries Elizabeth Ngwu elizabeth.ngwu@unn.edu.ng +23408039223452 No 35 Umunkanka Street, University of Nigeria, Nsukka.
City Postal code Country Position/Affiliation
Nsukka 0234 Nigeria Professor. Universoty of Nigeria Nsukka.
Role Name Email Phone Street address
Scientific Enquiries Ifeoma Afiaenyi ifeoma.nwachi@unn.edu.ng +23408061128753 No 10 C Catherine Rest House Road, Onuiyi Nsukka
City Postal code Country Position/Affiliation
Nsukka 0234 Nigeria Lecturer 1. University of Nigeria Nsukka.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data like background information, lifestyle characteristics, physical assessment (anthropometry and blood pressure) and biochemical data (fasting blood glucose, lipid profile and haematological parameters) will be made available after the journal publication of the article Informed Consent Form Individual Participant Data will be made available after publication hopefully as from May 2021. Individual Participant Data will be made available to the scientific community who may need it for meta analyses or any other legitimate research exercise
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available Yes There was no significant (p > 0.05) difference in the waist circumference and waist hip ratio in all the groups after the feeding trial. There was no significant (p > 0.05) difference in the fasting blood glucose in all the groups after the feeding trial. Groups 3 (experimental group that consumed 40 g of Moringa oleifera leaves per day) and 4 (experimental group that consumed 60 g of Moringa oleifera leaves per day) had a significant (p < 0.05) decrease in their mean systolic pressure after the feeding trial. No significant (p > 0.05) difference was seen in the mean diastolic pressure and mean total cholesterol of the subjects after the feeding trial. There was a significant (p < 0.05) increase in the mean triglyceride level of the subjects in group 3. A significant (p < 0.05) reduction in low density lipoprotein was seen in group 2 (experimental group that consumed 20 g of Moringa oleifera per day) subjects. Group 3 subjects had significant (p < 0.05) increase in their mean very low density lipoprotein after the feeding trial. There was a significant (p < 0.05) increase in the mean high density lipoprotein in groups 1, 2 and 4. Significant (p < 0.05) reduction in the mean haemoglobin level, packed cell volume and white blood cell count was seen only in group 4 subjects. Significant changes observed in the parameters assessed were not dose dependent. 28/04/2020 04/05/2021
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