NCT04117828

Brief Summary

Glycemic Index is a system of classification of different foods with significant levels of carbohydrates based on how they affect blood glucose levels after being consumed. In this study we will compare glycemic index of different varieties

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

6 days

First QC Date

October 4, 2019

Last Update Submit

November 7, 2019

Conditions

Glycemic Index and Glycemic Load

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose level

    Estimation of glycemic index and glycemic load

    1 week

Study Arms (4)

Control

ACTIVE COMPARATOR

50 g of glucose will be given to the individuals

Dietary Supplement: Dates

1st Intervention group

EXPERIMENTAL

50 g of Aseel dates will be given to the individuals

Dietary Supplement: Dates

2nd Intervention group

EXPERIMENTAL

50 g of Ajwa dates will be given to the individuals

Dietary Supplement: Dates

3rd Intervention group

EXPERIMENTAL

50 g of Karbala dates will be given to the individuals

Dietary Supplement: Dates

Interventions

DatesDIETARY_SUPPLEMENT

Phoenix dactylifera, commonly known as date or date palm is a flowering plant species in the palm family, Arecaceae. Dates are the fruit of the date palm tree, which is grown in many tropical regions of the world. Dates provide a wide range of essential nutrients, and has certain protective effects on health of individuals.

1st Intervention group2nd Intervention group3rd Intervention groupControl

Eligibility Criteria

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

You may qualify if:

  • General population from AKU
  • Adult ages (18- 60 years) will be included in the study

You may not qualify if:

  • Individuals with Dates/Ajwa allergy
  • Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agha Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Interventions

Chronology as Topic

Intervention Hierarchy (Ancestors)

TimePhysical Phenomena

Study Officials

  • Naseer Ahmed, Ph.D

    AKU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naseer Ahmed, Ph.D

CONTACT

3333382013dr.naseer99@gmail.com

Javeria Farooq, M.Phil

CONTACT

javeria.farooq@aku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 40 participants will be included in the study and will be divided into four groups. The AKU faculty and staff will be invited to MDL with fasting of 12 hr. Written informed consent (a copy will also be provided to the participant) will be taken from each individual.Following vitals will be measured body weight, height and blood pressure. 1st group will be the control that will consume 50 g of glucose and 2nd, 3rd, and 4th group will consume 50 g of different kinds of dates. Their blood sugar level will be checked at 0, 30, 60, 90 and 120 mins. Glycemic index and glycemic load will be calculated and will be compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 7, 2019

Study Start

October 14, 2019

Primary Completion

October 20, 2019

Study Completion

November 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

PA(1)