Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-04 @ 12:34 AM
Study NCT ID:
NCT04616066
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2020-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Date Fruit Effects in Type 2 Diabetes
Sponsor:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Organization:
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 2,000 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 23.3%; 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 2,000 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 329ug/100g), in accord with that advised in the Holy Qur'an, 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 9.6ug/100g). 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 2,000 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 329ug/100g), in accord with that advised in the Holy Qur'an, 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 9.6ug/100g). Each intervention will be taken as a snack mid-morning and mid-afternoon.
Study Oversight
Has Oversight DMC:
True
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?: