- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01422668
Effect of Coffee Consumption on the Glycemic Index of Khalas Dates Tested in Healthy and Diabetic Subjects
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
AB
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Al Ain, AB, United Arab Emirates
- Faculty of Medicine and Health Sciences UAE University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: GI of Khalas dates
The Glycemic indices of the Khalas dates were measured for healthy and diabetic subjects.
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every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates
|
|
EXPERIMENTAL: GI of the Khalas dates with Coffee
measuring the effect of 100 ml of coffee consumption on the GI of the Khalas dates among healthy and diabetic subjects.
|
every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Index of Khalas dates with and without coffee
Time Frame: 2 or 3 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juma M Alkaabi, MD, Assistant professor Internal Medicine Department FMHS UAE University
- Study Chair: Bayan Al-Dabbag, PhD, FMHS UAE University
- Study Chair: Hussein Saadi, MD, Professor of Medicine, FMHS UAE University
- Study Chair: Salah Gariballa, MD, Professor of Medicine FMHS UAE University
- Study Chair: Yasin Javed, Msc, FMHS UAE University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UAEU: GI Dates Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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