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.: PACTR202007535462447 Date of Approval: 08/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Biscuit study
Official scientific title Development of a functional biscuit with a low glycemic index with early insulin secretion potential in type 2 diabetes patients: results from a controlled clinical trial.
Brief summary describing the background and objectives of the trial Glycemic control plays a crucial role in the progression and evolution of diabetes. There exists,in our milieu, limited access of patients to conventional drugs. Being aware of the potential anti diabetic properties of some local cooking ingredients (moringa oleifera, zea mays, zingiber officinale), we decided to combine these to form a biscuit, sweetened with xylitol. This study seeks to determine its glycemic index, and to evaluate its effect on glycemic and insulin reponse during a meal
Type of trial CCT
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 Education /Training
Anticipated trial start date 11/12/2017
Actual trial start date 15/01/2018
Anticipated date of last follow up 28/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 23
Actual target sample size (number of participants) 23
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Non diabetic group twice 2 days apart After selection, the healthy non diabetic subjects were scheduled to partake in two study meals, within a 2-day period. They were advised to maintain minimal physical activity level the day preceding each visit, and to undergo an 8 hour overnight fast before the intervention. The meal studies were a standard oral glucose tolerance test on the first day, and then ingestion of the functional biscuits (containing an equivalent of 75g of glucose) 2 days later. Capillary blood glucose was measured before each meal, (fasting), and subsequently at 30, 60, 90, and 120 mins after the onset of both meals. The glycemic index of the biscuit was determined in these healthy subjects, and recorded. 10 Uncontrolled
Experimental Group Diabetic group Twice Within 7 days The next step was to evaluate glycemic and insulin responses in a population of diabetic patients. The intervention consisted in administering a mixed meal test to a diabetic subject with 50g of carbohydrates taken in the form of a functional biscuit (i.e. 94g of biscuits). The same individual then received 121g of wholemeal bread, within the next 7 days. Wholemeal bread was chosen as the control meal for this study because it is the reference carbohydrate for dietary prescription in our setting. The meal test was performed in the morning (between 7 and 10 AM) after an overnight fast, with no food or drink (with the exception of water) and patients took no short acting insulin at least 6h prior to the test. Meals were ingested over 10 minutes and blood was taken every 15 minutes, in both meal procedures, and was used to measure plasma glycemia and C peptide. 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ten healthy early adult volunteers, non-obese with no history of diabetes, hypertension or gastrointestinal tract surgery, were included in the study, after they had given a written informed consent. Thirteen (13) patients subjects with type 2 diabetes, followed at the National Obesity Centre, who have been on regular antidiabetic treatment for at least 3 months, and who had agreed to participate in the study . Any subject who had experienced acute complications for at least 1 month prior to the study. Any subject who presented any acute complication of diabetes or any other comorbidity during the study. Pregnant women. Subjects with impaired liver or kidney function. Subects with HIV/AIDS or on antiretroviral drugs. Any subect who had not respected the precautions necessary for the Mixed meal test Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 11/01/2018 Center Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Province Yaounde 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome variation of the area under the postprandial glucose curve with biscuit administration End of study
Secondary Outcome variation of the area under the insulin curve with biscuit administration. end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National obesity center Central hospital Yaounde Cameroon. Education Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Financies and resources Nsimeyong Yaounde Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yves Florent Wasnyo Nsimeyong Yaounde 00237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Batakeh Ba Agoons Mendong Yaounde Cameroon
Emile Camille Noubissi Nouno Dijon Dijon France
Jean Claude Katte Biyem Assi Yaounde Cameroon
Serge Rostand Gouetna Biyem Assi Yaounde Cameroon
Isabelle Mboutchuin Kamdem Ngousso Yaounde Cameroon
Saint Just Petnga Douala Douala Cameroon
Jan Ren Nkeck Yaounde Yaounde Cameroon
Francky Teddy Endomba Dijon Dijon France
Magellan Guewo Fokeng Ngoa Ekelle Yaounde Cameroon
Eugne Sobngwi Mvan Yaounde Cameroon
Emmanuel Nnanga Nga Yaounde Yaounde Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yves Florent Wasnyo yveswasnyo@gmail.com +237699870446 Yaounde, Nsimeyong
City Postal code Country Position/Affiliation
Yaounde Cameroon National Obesity Center of Yaounde Central Hospital
Role Name Email Phone Street address
Public Enquiries Jean Claude Katte jckatte@gmail.com +237677587929 Etoug Ebe
City Postal code Country Position/Affiliation
Yaounde Cameroon Fellow Global Health Research University of Exeter UK.
Role Name Email Phone Street address
Scientific Enquiries Eugene Sobngwi sobngwieugene@yahoo.fr +237675088750 Mvan
City Postal code Country Position/Affiliation
Yaounde Cameroon National Obesity Center Yaounde Central Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Before being made available, consent will be sought from all trial participants. from trial participants with adequate assurance that patient privacy and confidentiality can be maintained Study Protocol 3 months after results available By email requests from primary investigator
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