Date Fruit Effects in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Date Fruit Phytoestrogen on the Glycemic Control of Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Other: Dates
* Other: Raisins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of type 2 diabetes will be based on the WHO guidelines. An HbA1C of 6.5% or greater, or 2 fasting plasma glucose readings of >7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meets the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed. Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. HbA1c 7.5 - 10% Patients between the ages of 45-75 years at the start of the study. Capable to give informed consent and complete the study. Exclusion Criteria: Patients with concurrent illness or any medication in the last 3 months. Patients who are taking hormone replacement therapy. Patients who are currently or have taken antibiotics in the last 3 months. Currently enrolled in other clinical trials. Hba1c at recruiting stage of more than 10%. Patients with a BMI less than 20 and more than 40. Patients with known food allergies. Patients on insulin. Patients who are eating dates or raisins should be washed out for 4 weeks. Pregnant or nursing, or plans to become pregnant in the next 3 months, or not using adequate contraceptive measures.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel, prospective, interventional and randomized trial involving 80 patients with type 2 diabetes. They will be randomised to either 60g of dates or 60g of raisins (amount split and given as a mid-morning and mid-afternoon snack) for 3 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dates Arm<br>Consumption of Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g) | Other: Dates<br>* The effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes<br>|
| Experimental: Raisins Arm<br>Consumption of Raisins (30g twice daily, phytoestrogen content of 9.6ug/100g) | Other: Raisins<br>* The effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes | Measuring the levels of phytoestrogen and evaluate if it has reduced the average blood sugar levels over a period of 3 months. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether date phytoestrogens affect cardiovascular risk | Determine whether the level of phytoestrogens has lowered risks of cardiovascular disease by measuring the fasting lipids, C reactive protein and blood pressure. | 90 days | 
| Determine whether date phytoestrogens affect insulin resistance | Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type2 diabetes, Dates, Phytoestrogen