Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616066
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2020-10-25
Brief Title:
Date Fruit Effects in Type 2 Diabetes
Sponsor:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Organization:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Study Overview
Official Title:
Effect of Date Fruit Phytoestrogen on the Glycemic Control of Patients With Type 2 Diabetes A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dried dates Phoenix dactylifera have the second highest phytoestrogen content of any fruit only secondary to dried apricots with 329ug of phytoestrogens per 100g The date palm is one of oldest planted trees on the earth at around 2000 years old Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies Date sugars have also been shown to be phenol rich potent antioxidant and strong inhibitor of α -glycosidase that may also have benefit in diabetes In addition dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes
The objective of this study is to investigate the effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes in comparison to the same glycemic load of raisins that have low phytoestrogen content
The objective of this study is to investigate the effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes in comparison to the same glycemic load of raisins that have low phytoestrogen content
Detailed Description:
Production and consumption of soy foods within Western countries have increased dramatically in the last decade with the postulated health benefits including improvement in bone health relief of menopausal symptoms and reduced risk of certain types of cancers due to the soy phytoestrogens In addition habitual intake of soy phytoestrogens has also been associated with a reduced risk of type 2 diabetes mellitus T2DM and cardiovascular disease CVD which is of particular relevance given the increasing global prevalence of diabetes This is a particular problem here in the Middle East and North Africa MENA region where diabetes is considered as a serious and increasing health problem According to the International Diabetes Federation the prevalence of diabetes in the MENA region is over 233 however worldwide there is an epidemic increase in type 2 diabetes with the WHO report that approximately 415 million people have diabetes worldwide and that by 2030 diabetes will be the 7th leading cause of death
Dried dates Phoenix dactylifera have the second highest phytoestrogen content of any fruit only secondary to dried apricots with 329ug of phytoestrogens per 100g The date palm is one of oldest planted trees on the earth at around 2000 years old Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies Date sugars have also been shown to be phenol rich potent antioxidant and strong inhibitor of α -glycosidase that may also have benefit in diabetes In addition dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes
There has not been a medium term study of the effect of date fruit in diabetes therefore this study will determine if the consumption Khalas dates 3 dates 30g undried dates twice daily phytoestrogen content 329ug100g in accord with that advised in the Holy Quran will improve the glycemic control in men with type 2 diabetes in comparison with the equivalent glycemic load of raisins 30g twice daily phytoestrogen content of 96ug100g Each intervention will be taken as a snack mid-morning and mid-afternoon
Dried dates Phoenix dactylifera have the second highest phytoestrogen content of any fruit only secondary to dried apricots with 329ug of phytoestrogens per 100g The date palm is one of oldest planted trees on the earth at around 2000 years old Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies Date sugars have also been shown to be phenol rich potent antioxidant and strong inhibitor of α -glycosidase that may also have benefit in diabetes In addition dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes
There has not been a medium term study of the effect of date fruit in diabetes therefore this study will determine if the consumption Khalas dates 3 dates 30g undried dates twice daily phytoestrogen content 329ug100g in accord with that advised in the Holy Quran will improve the glycemic control in men with type 2 diabetes in comparison with the equivalent glycemic load of raisins 30g twice daily phytoestrogen content of 96ug100g Each intervention will be taken as a snack mid-morning and mid-afternoon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None