Date Fruit Effects in Type 2 Diabetes

NCT04616066 | Completed DMC

• 1 other identifier: 89 / 25-Oct-2020
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

Type2 diabetes; Dates; Phytoestrogen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine whether date phytoestrogens affect cardiovascular risk

  90 days

• Determine whether date phytoestrogens affect insulin resistance

  90 days

Study Arms (2)

Dates Arm

EXPERIMENTAL

Consumption of Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g)

Other: Dates

Raisins Arm

EXPERIMENTAL

Consumption of Raisins (30g twice daily, phytoestrogen content of 9.6ug/100g)

Other: Raisins

Interventions

Dates OTHER

The effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes

Dates Arm

Raisins OTHER

The effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes

Raisins Arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• King Hamad University Hospital, Bahrain: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland - Bahrain

Manama, Bahrain

Location

Related Publications (12)

• Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008 Jun;138(6):1244S-9S. doi: 10.1093/jn/138.6.1244S.

  PMID: 18492864 BACKGROUND

• Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.

  PMID: 12351466 BACKGROUND

• Xu SZ, Zeng B, Daskoulidou N, Chen GL, Atkin SL, Lukhele B. Activation of TRPC cationic channels by mercurial compounds confers the cytotoxicity of mercury exposure. Toxicol Sci. 2012 Jan;125(1):56-68. doi: 10.1093/toxsci/kfr268. Epub 2011 Oct 9.

  PMID: 21984481 BACKGROUND

• Thompson LU, Boucher BA, Liu Z, Cotterchio M, Kreiger N. Phytoestrogen content of foods consumed in Canada, including isoflavones, lignans, and coumestan. Nutr Cancer. 2006;54(2):184-201. doi: 10.1207/s15327914nc5402_5.

  PMID: 16898863 BACKGROUND

• Vayalil PK. Date fruits (Phoenix dactylifera Linn): an emerging medicinal food. Crit Rev Food Sci Nutr. 2012;52(3):249-71. doi: 10.1080/10408398.2010.499824.

  PMID: 22214443 BACKGROUND

• Hamad I, AbdElgawad H, Al Jaouni S, Zinta G, Asard H, Hassan S, Hegab M, Hagagy N, Selim S. Metabolic Analysis of Various Date Palm Fruit (Phoenix dactylifera L.) Cultivars from Saudi Arabia to Assess Their Nutritional Quality. Molecules. 2015 Jul 27;20(8):13620-41. doi: 10.3390/molecules200813620.

  PMID: 26225946 BACKGROUND

• Alkaabi JM, Al-Dabbagh B, Ahmad S, Saadi HF, Gariballa S, Ghazali MA. Glycemic indices of five varieties of dates in healthy and diabetic subjects. Nutr J. 2011 May 28;10:59. doi: 10.1186/1475-2891-10-59.

  PMID: 21619670 BACKGROUND

• Alkaabi J, Al-Dabbagh B, Saadi H, Gariballa S, Yasin J. Effect of traditional Arabic coffee consumption on the glycemic index of Khalas dates tested in healthy and diabetic subjects. Asia Pac J Clin Nutr. 2013;22(4):565-73. doi: 10.6133/apjcn.2013.22.4.09.

  PMID: 24231017 BACKGROUND

• Miller CJ, Dunn EV, Hashim IB. The glycaemic index of dates and date/yoghurt mixed meals. Are dates 'the candy that grows on trees'? Eur J Clin Nutr. 2003 Mar;57(3):427-30. doi: 10.1038/sj.ejcn.1601565.

  PMID: 12627179 BACKGROUND

• Senn SJ. Covariate imbalance and random allocation in clinical trials. Stat Med. 1989 Apr;8(4):467-75. doi: 10.1002/sim.4780080410.

  PMID: 2727470 BACKGROUND

• Senn S. Testing for baseline balance in clinical trials. Stat Med. 1994 Sep 15;13(17):1715-26. doi: 10.1002/sim.4780131703.

  PMID: 7997705 BACKGROUND

• Knol MJ, Groenwold RH, Grobbee DE. P-values in baseline tables of randomised controlled trials are inappropriate but still common in high impact journals. Eur J Prev Cardiol. 2012 Apr;19(2):231-2. doi: 10.1177/1741826711421688. No abstract available.

  PMID: 22512015 BACKGROUND

MeSH Terms

Interventions

Chronology as Topic

Intervention Hierarchy (Ancestors)

Time; Physical Phenomena

Study Officials

• Naji Alamuddin, Dr.

  Royal College of Surgeons in Ireland - Bahrain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 4, 2020
• Study Start: October 10, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, 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.

Locations

BA (1)