Glycemic Index and Glycemic LoadNCT04117828
Assessment of Glycemic Index of Different Dates
A study testing Dates in people with Glycemic Index and Glycemic Load, run by Aga Khan University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index and Glycemic Load
- What is being tested?
- Dates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2019to Nov 2019
- Phase
- Interventional
- 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
- General population from AKU
- Adult ages (18- 60 years) will be included in the study
Who cannot join
- Individuals with Dates/Ajwa allergy
- Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded
Trial locations and contacts
1 site in 1 country.
Javeria Farooq, M.Phil contact
Pakistan1 site, 1 recruiting
- Recruiting
Agha Khan University Hospital
Karachi, Sindh, 74800
Naseer Ahmed, Ph.D, 3333382013, dr.naseer99@gmail.com
About this study
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
Read the detailed description
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. Despite being a significant parameter of blood glucose, GI does not depict the effect of the food when taken in a controlled recommended amount, and so the Glycemic Loads (GL) must also be calculated, thereby measuring the impact on glycemic levels after consumption of standard food portion sizes. Dates are high energy foods consumed in various parts of the world, are known to be a source of several important nutrients and are also shown to have significant impacts in preventing illnesses due to their anti-inflammatory and anti-microbial actions as well as preventative action against oxidative reactions The greatly frequent consumption of dates necessitates the identification of their GI and GL to ensure whether consumption is beneficial and safe for individuals. The objective of the study is to determine and compare the values of GI and GL of three varieties of dates in order to assess their safe consumption by individuals
- Conditions
- Glycemic Index and Glycemic Load
- Being tested
- Dates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 50 g of glucose will be given to the individuals Receives: Dietary Supplement: Dates |
| 1st Intervention group | Experimental | 50 g of Aseel dates will be given to the individuals Receives: Dietary Supplement: Dates |
| 2nd Intervention group | Experimental | 50 g of Ajwa dates will be given to the individuals Receives: Dietary Supplement: Dates |
| 3rd Intervention group | Experimental | 50 g of Karbala dates will be given to the individuals Receives: Dietary Supplement: Dates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose level
Estimation of glycemic index and glycemic load
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start14 Oct 2019
- Primary completion20 Oct 2019
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic Index and Glycemic LoadStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NASEER AHMED, Aga Khan University
- Investigators
- Naseer Ahmed, Ph.D, Principal investigator, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117828
- Sponsor's protocol ID
- NA124
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Glycemic Index of Different Dates
- ClinicalTrials.gov ID
- NCT04117828
- Acronym / sponsor ID
- NA124
- Conditions
- Glycemic Index and Glycemic Load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Oct 2019 (actual)
- 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.
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
Detailed description
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. Despite being a significant parameter of blood glucose, GI does not depict the effect of the food when taken in a controlled recommended amount, and so the Glycemic Loads (GL) must also be calculated, thereby measuring the impact on glycemic levels after consumption of standard food portion sizes. Dates are high energy foods consumed in various parts of the world, are known to be a source of several important nutrients and are also shown to have significant impacts in preventing illnesses due to their anti-inflammatory and anti-microbial actions as well as preventative action against oxidative reactions The greatly frequent consumption of dates necessitates the identification of their GI and GL to ensure whether consumption is beneficial and safe for individuals. The objective of the study is to determine and compare the values of GI and GL of three varieties of dates in order to assess their safe consumption by individuals
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Dates50 g of glucose will be given to the individuals |
| 1st Intervention group | Experimental | Dietary Supplement: Dates50 g of Aseel dates will be given to the individuals |
| 2nd Intervention group | Experimental | Dietary Supplement: Dates50 g of Ajwa dates will be given to the individuals |
| 3rd Intervention group | Experimental | Dietary Supplement: Dates50 g of Karbala dates will be given to the individuals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- General population from AKU
- Adult ages (18- 60 years) will be included in the study
Key exclusion criteria (2 listed)
- Individuals with Dates/Ajwa allergy
- Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded
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 |
|---|---|---|
| DatesPhoenix 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. | Dietary supplement | 1st Intervention group, 2nd Intervention group, 3rd Intervention group, Control |
Primary outcome
Blood Glucose level
Time frame: 1 week
Estimation of glycemic index and glycemic load
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
Javeria Farooq, M.Phil contact
Naseer Ahmed, Ph.D principal investigator
AKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dates in people with Glycemic Index and Glycemic Load, run by Aga Khan University at 1 site in Pakistan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2019. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naseer Ahmed, Ph.D (3333382013, dr.naseer99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose level (time frame: 1 week). 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 8 Nov 2019.