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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01422668
Other study ID # UAEU: GI Dates Study
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2011
Last updated August 23, 2011
Start date March 2010
Est. completion date June 2010

Study information

Verified date August 2011
Source United Arab Emirates University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to evaluate the composition of Khalas, a very common type of dates used in the UAE and to determine the effects of drinking Arabic coffee on the results of GI tests in both healthy and diabetic subjects.


Description:

Background:The consumption of dates along with coffee is a deeply rooted habit in many societies. This study was designed to determine the effect of coffee consumption on the glycemic index of a common variety of dates (Khalas) tested in healthy subjects and individuals with type 2 diabetes mellitus.

Methods:Composition analysis was carried out for Khalas dates (Tamer stage) and the weight of the dates flesh equivalent to 50 g of available carbohydrate was calculated. The study subjects were thirteen healthy volunteers with a mean (± SD) age of 40.2 ± 6.7 years and ten participants with type 2 diabetes mellitus (controlled on lifestyle measures and/or metformin) with a mean HbA1c (± SD) of 6.6 ± (0.7 %) and a mean age (± SD) of 40.8 ± 5.7 years. Each subject was tested on five separate days with 50 g of glucose (on 3 occasions) and 50 g equivalent of available carbohydrates from the dates without coffee (on one occasion) and with coffee (on another occasion). Capillary glucose was measured in the healthy subjects at 0, 15, 30, 45, 60, 90 and 120 min and for the diabetics at 0, 30, 60, 90, 120, 150 and 180 min. The glycemic indices were determined as ratios of the incremental areas under the response curves for the dates alone/with coffee compared to glucose. Statistical analyses were performed using Student's t-tests.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- required that those in the healthy group were healthy and in the diabetes group that their diabetes was controlled (HbA1c =8%) on diet with or without metformin

Exclusion Criteria:

- morbid obesity (BMI > 40 kg/m2)

- pre diabetes

- pregnancy

- presence of gastroenterological disorders

- alimentary tract surgery

- a history of gastroenteritis in the prior six months

- any alcohol intake

- smoking

- taking any medications (except metformin)

- poorly controlled diabetes (HbA1c > 8%) and the presence of acute or chronic diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Khalas dates
every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates

Locations

Country Name City State
United Arab Emirates Faculty of Medicine and Health Sciences UAE University Al Ain AB

Sponsors (1)

Lead Sponsor Collaborator
United Arab Emirates University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycemic Index of Khalas dates with and without coffee Every subject recieved 50 grams reducing sugars of Khalas dates with and without coffee. Measuring glucose level over 2 hours in Healthy subjects and over 3 hours in diabetic subjects as per a standard protocol. 2 or 3 hours
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