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The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects (Dates)

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ClinicalTrials.gov Identifier: NCT01307904
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
Sponsor:
Collaborator:
Abu Dhabi Food Control Authority
Information provided by:
United Arab Emirates University

Tracking Information
First Submitted Date  ICMJE March 2, 2011
First Posted Date  ICMJE March 3, 2011
Last Update Posted Date March 3, 2011
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
Dates Glycemic Index [ Time Frame: 4 months ]
Measuring the composition of dates, selection of patients and carrying out the study
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects
Official Title  ICMJE The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects
Brief Summary

The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study.

The dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).

The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items.

Detailed Description

The United Arab Emirates (UAE) has transitioned rapidly over the last 40 years. This has lead to a dramatic increase in the prevalence of obesity, metabolic syndrome, dyslipidaemia, hypertension, prediabetes and diabetes. Daily consumption of dates is the norm.The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested equally in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study. The dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).

The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items with potential health benefits for healthy and diabetic individuals alike.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Other: Glucose
    Each healthy and Diabetic volunteers received 50 grams of glucose
  • Other: Dates
    Each healthy and diabetic volunteers received 50 grams equivalent of carbohydrates of each of the five selected dates, on five separate days.
Study Arms  ICMJE
  • Active Comparator: dates
    Each healthy and diabetic subjects received 50 grams equivalent of carbohydrates of the tested dates, On five separate days.
    Intervention: Other: Dates
  • Active Comparator: sugar
    Each healthy and diabetic subjects received 50 grams of glucose
    Intervention: Other: Glucose
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2011)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult
  • Healthy or having controlled type 2 diabetes mellitus

Exclusion Criteria:

  • Morbid obesity (BMI > 40)
  • Presence of gastroenterological disorders
  • Alimentary tract surgery
  • A history of gastroenteritis in the prior six months
  • Any disease that may affect glucose metabolism
  • Alcohol intake
  • Smoking
  • Taking any medications (except metformin)
  • Poorly uncontrolled diabetes (HbA1c > 8%)
  • The presence of chronic diseases or the presence of acute illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307904
Other Study ID Numbers  ICMJE UAEU Dates GI Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juma M Alkaabi, Faculty of Medicine and Health Sciences - UAE University
Study Sponsor  ICMJE United Arab Emirates University
Collaborators  ICMJE Abu Dhabi Food Control Authority
Investigators  ICMJE
Principal Investigator: Juma M Alkaabi, MD Faculty of Medicine and Health Sciences, UAE University
Study Director: Bayan Al-Dabbagh, PhD Faculty of Medicine and Health Sciences, UAE University
Study Director: Professor Hussein saadi, MD Faculty of Medicine and Health Sciences, UAE University
Study Director: Professor Salah Gariballa, FRCP Faculty of Medicine and Health Sciences, UAE University
Study Director: Ahmed Shakeel, PhD Abu Dhabi Food Control Authority
Study Director: Mustafa Al Gazali, PhD Abu Dhabi Food Control Authority
PRS Account United Arab Emirates University
Verification Date March 2010

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