NCT01422668

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

3 months

First QC Date

August 18, 2011

Last Update Submit

August 23, 2011

Conditions

Keywords

Glycemic indexDatesDiabetesCoffee

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

GI of Khalas dates

ACTIVE COMPARATOR

The Glycemic indices of the Khalas dates were measured for healthy and diabetic subjects.

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.

Other: Khalas dates

Interventions

every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates

GI of Khalas datesGI of the Khalas dates with Coffee

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine and Health Sciences UAE University

Al Ain City, AB, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Juma M Alkaabi, MD

    Assistant professor Internal Medicine Department FMHS UAE University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Faculty of Medicine and Health Sciences

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 24, 2011

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations