Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590519
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Date Seed Extract in Controlling Diabetes and Reducing Cardiovascular Risk in Patients With Type 2 Diabetes in Riyadh Saudi Arabia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Globally chronic noncommunicable diseases rank as the leading cause of morbidity and mortality Diabetes is reaching high epidemic proportions across the globe The prevalence of diabetes is increasing in Saudi Arabia with diabetes affecting 141 of the population across all age groups and 28 of those over the age of 30 Date seed intake is one of the best-studied patterns Previous studies findinds showed that the phenolic compounds in date seeds have blood sugar-lowering properties There is a lack of data on how date seed diets may affect glycaemia control and cardiovascular risk among Saudi Arabian patients with T2DM Therefore randomised controlled trials RCTs will be conducted to assess the effects of date seeds on glycaemic control and cardiovascular risk among diabetes patients
Detailed Description:
A randomized controlled trial study will be conducted among adults with Type 2 diabetes who referred to the diabetes center to optimise dietary intervention for diabetes control in King Fahad Medical City KFMC Riyadh Saudi Arabia A total of 160 participants 80 participants for each group will be select using simple random sampling
The intervention group will receive a capsule of date-seed powder while the control group will not receive any capsule Each person should consume 5 grams two capsules of date-seed powder twice daily after meals for three months Assessments are carried out at the beginning of the study one month and two months after the intervention Chan et al 2013 Participants will be contacted twice a week to ensure that they are adhering to the rules maintaining their physical activity and clarifying any questions about taking supplements A checklist is also provided to all participants to monitor their adherence Participants who fail to take more than 10 of the packs will be excluded from the study
For the preparation of date seeds Sukkari firstly the desired concentrations of date seed powder for the different versions of Sukkari are determined Secondly the amount of date seed powder required for each concentration is calculated based on the total volume of the product Then separate containers are prepared for each version of Sukkari A grinder is used to extract the bioactive substances from the date seeds and prepare the powder First the date seeds are washed and dried Then we use a grinder and grind them into powder Finally gelatin capsules will be filled with date kernel powder and then packed in identical containers
The data will be collected from the intervention and control group before the intervention one month after the intervention and two months follow-up after the intervention data collection through a self-administered questionnaire The questionnaire will be consisted of eight sections aimed at obtaining information on socio-demographic data lifestyle characteristics and clinical parameters of the study participants Accordingly dietary data and physical measurements including anthropometric measurements blood pressure and biochemical parameters will be collected Data will be analyzed by using the software Statistical Package for Social Sciences SPSS version 26
The intervention group will receive a capsule of date-seed powder while the control group will not receive any capsule Each person should consume 5 grams two capsules of date-seed powder twice daily after meals for three months Assessments are carried out at the beginning of the study one month and two months after the intervention Chan et al 2013 Participants will be contacted twice a week to ensure that they are adhering to the rules maintaining their physical activity and clarifying any questions about taking supplements A checklist is also provided to all participants to monitor their adherence Participants who fail to take more than 10 of the packs will be excluded from the study
For the preparation of date seeds Sukkari firstly the desired concentrations of date seed powder for the different versions of Sukkari are determined Secondly the amount of date seed powder required for each concentration is calculated based on the total volume of the product Then separate containers are prepared for each version of Sukkari A grinder is used to extract the bioactive substances from the date seeds and prepare the powder First the date seeds are washed and dried Then we use a grinder and grind them into powder Finally gelatin capsules will be filled with date kernel powder and then packed in identical containers
The data will be collected from the intervention and control group before the intervention one month after the intervention and two months follow-up after the intervention data collection through a self-administered questionnaire The questionnaire will be consisted of eight sections aimed at obtaining information on socio-demographic data lifestyle characteristics and clinical parameters of the study participants Accordingly dietary data and physical measurements including anthropometric measurements blood pressure and biochemical parameters will be collected Data will be analyzed by using the software Statistical Package for Social Sciences SPSS version 26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None