NCT01307904

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1 diabetes-mellitus

Timeline
Completed

Started Mar 2010

Shorter than P25 for early_phase_1 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2010

Enrollment Period

Same day

First QC Date

March 2, 2011

Last Update Submit

March 2, 2011

Conditions

Diabetes Mellitus

Keywords

Glycemic indexDatesBlood glucose

Outcome Measures

Primary Outcomes (1)

  • Dates Glycemic Index

    Measuring the composition of dates, selection of patients and carrying out the study

    4 months

Study Arms (2)

dates

ACTIVE COMPARATOR

Each healthy and diabetic subjects received 50 grams equivalent of carbohydrates of the tested dates, On five separate days.

Other: Dates

sugar

ACTIVE COMPARATOR

Each healthy and diabetic subjects received 50 grams of glucose

Other: Glucose

Interventions

GlucoseOTHER

Each healthy and Diabetic volunteers received 50 grams of glucose

sugar
DatesOTHER

Each healthy and diabetic volunteers received 50 grams equivalent of carbohydrates of each of the five selected dates, on five separate days.

dates

Eligibility Criteria

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

You may qualify if:

  • Adult
  • Healthy or having controlled type 2 diabetes mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department, FMHS, UAE University

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (1)

  • 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.

    PMID: 21619670DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

GlucoseChronology as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesTimePhysical Phenomena

Study Officials

  • Juma M Alkaabi, MD

    Faculty of Medicine and Health Sciences, UAE University

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 3, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

March 3, 2011

Record last verified: 2010-03

Locations

AE(1)