Diabetes MellitusPhase 3NCT01422668
Effect of Coffee Consumption on the Glycemic Index of Khalas Dates Tested in Healthy and Diabetic Subjects
A Phase 3 study testing Khalas dates in people with Diabetes Mellitus, run by United Arab Emirates University at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Khalas dates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Mar 2010to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- any alcohol intake
- smoking
- taking any medications (except metformin)
- poorly controlled diabetes (HbA1c > 8%) and the presence of acute or chronic diseases
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Faculty of Medicine and Health Sciences UAE University
Al Ain City, AB
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Khalas dates
- Keywords
- Glycemic index, Dates, Diabetes, Coffee
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khalas datesOther
every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates
| Study group | Role | What they receive |
|---|---|---|
| GI of Khalas dates | Active comparator | The Glycemic indices of the Khalas dates were measured for healthy and diabetic subjects. Receives: Other: Khalas dates |
| GI of the Khalas dates with Coffee | Experimental | measuring the effect of 100 ml of coffee consumption on the GI of the Khalas dates among healthy and diabetic subjects. Receives: Other: Khalas dates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 or 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juma Alkaabi, United Arab Emirates University
- Investigators
- Juma M Alkaabi, MD, Principal investigator, Assistant professor Internal Medicine Department FMHS UAE UniversityBayan Al-Dabbag, PhD, Study chair, FMHS UAE universityHussein Saadi, MD, Study chair, Professor of Medicine, FMHS UAE UniversitySalah Gariballa, MD, Study chair, Professor of Medicine FMHS UAE UniversityYasin Javed, Msc, Study chair, FMHS UAE University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422668
- Sponsor's protocol ID
- UAEU: GI Dates Study
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Consumption on the Glycemic Index of Khalas Dates Tested in Healthy and Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01422668
- Acronym / sponsor ID
- UAEU: GI Dates Study
- Conditions
- Diabetes Mellitus
- Keywords
- Glycemic index, Dates, Diabetes, Coffee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GI of Khalas dates | Active comparator | Other: Khalas datesThe Glycemic indices of the Khalas dates were measured for healthy and diabetic subjects. |
| GI of the Khalas dates with Coffee | Experimental | Other: Khalas datesmeasuring the effect of 100 ml of coffee consumption on the GI of the Khalas dates among healthy and diabetic subjects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- morbid obesity (BMI > 40 kg/m2)
- pre diabetes
- pregnancy
- presence of gastroenterological disorders
- alimentary tract surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khalas datesevery subject recieved 50 grams reducing carbohydrates equivalent of khalas dates | Other | GI of Khalas dates, GI of the Khalas dates with Coffee |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juma M Alkaabi, MD principal investigator
Assistant professor Internal Medicine Department FMHS UAE University
Bayan Al-Dabbag, PhD study chair
FMHS UAE university
Hussein Saadi, MD study chair
Professor of Medicine, FMHS UAE University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Khalas dates in people with Diabetes Mellitus, run by United Arab Emirates University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Index of Khalas dates with and without coffee (time frame: 2 or 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2011.