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Date Fruit Effects in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04616066
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
King Hamad University Hospital, Bahrain
Information provided by (Responsible Party):
Royal College of Surgeons in Ireland - Medical University of Bahrain

Tracking Information
First Submitted Date  ICMJE October 25, 2020
First Posted Date  ICMJE November 4, 2020
Last Update Posted Date June 8, 2021
Estimated Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2020)
The effect of phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes [ Time Frame: 90 days ]
Measuring the levels of phytoestrogen and evaluate if it has reduced the average blood sugar levels over a period of 3 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2020)
  • Determine whether date phytoestrogens affect cardiovascular risk [ Time Frame: 90 days ]
    Determine whether the level of phytoestrogens has lowered risks of cardiovascular disease by measuring the fasting lipids, C reactive protein and blood pressure.
  • Determine whether date phytoestrogens affect insulin resistance [ Time Frame: 90 days ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Date Fruit Effects in Type 2 Diabetes
Official Title  ICMJE Effect of Date Fruit Phytoestrogen on the Glycemic Control of Patients With Type 2 Diabetes: A Randomized Clinical Trial.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • Other: Dates
    The effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
  • Other: Raisins
    The effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
Study Arms  ICMJE
  • Experimental: Dates Arm
    Consumption of Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g)
    Intervention: Other: Dates
  • Experimental: Raisins Arm
    Consumption of Raisins (30g twice daily, phytoestrogen content of 9.6ug/100g)
    Intervention: Other: Raisins
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naji Alamuddin, Dr. +97335661736 naalamuddin@rcsi.com
Contact: Pearl Wasif, MSc. +97333180191 PSulaiman@rcsi-mub.com
Listed Location Countries  ICMJE Bahrain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04616066
Other Study ID Numbers  ICMJE 89 / 25-Oct-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame:

Dr Naji will act as the data custodian and is responsible for the storage, handling and quality of the study data.

Data will be collected in the case report form to allow for cross referencing to check validity.

Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.

Access Criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.
Responsible Party Royal College of Surgeons in Ireland - Medical University of Bahrain
Study Sponsor  ICMJE Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborators  ICMJE King Hamad University Hospital, Bahrain
Investigators  ICMJE
Principal Investigator: Naji Alamuddin, Dr. Royal College of Surgeons in Ireland - Bahrain
PRS Account Royal College of Surgeons in Ireland - Medical University of Bahrain
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP