Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit
1 other identifier
interventional
10
1 country
1
Brief Summary
Fruit of the date palm (P. dactylifera) may be considered as an emerging and potential candidate for the development of health-promoting foods, owing to its high nutritional values. Furthermore, aqueous extracts of dates have previously been shown to have potent antioxidant activity, because they inhibit in vitro lipid and protein oxidation and possess free radical scavenging capacity. Although the high sugar content of date fruit has always been a concern, date fruit has been regarded as a low-GI to medium-GI food. However, very limited, inconsistent and contradictory information is available on the glycaemic index values of different date varieties, which may be attributed to both the methodology as well as other food factors. Date consumption is high among people of Arabic origin, where it's very common for them to be eaten with coffee or yoghurt. Therefore, in view of these concerns, the objective of this trial is to evaluate the glycaemic response of two different varieties of dates, named Birhi \& Khassab, in an early maturation stage (Rutab stage), when mixed with 0% fat yogurt, on ten healthy participants aged between 18 and 45.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
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
March 27, 2018
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedDecember 7, 2018
December 1, 2018
2 months
March 27, 2018
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Blood glucose concentrations (mml/15 min)after the consumption Birhi
On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
Blood glucose concentrations (mml/15 min)after the consumption Khassab
On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
Blood glucose concentrations (mml/15 min)after the consumption Placebo
On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
Study Arms (3)
assessing the GI + GL of Birhi + YEO 0% fat yoghurt
EXPERIMENTAL47g of total carbohydrate in which contains 43.6g of Freeze-dried of Birhi powder+ 150g of 0% fat yoghurt
assessing the GI + GL of Khassab + YEO 0% fat yoghurt
EXPERIMENTAL47g of total carbohydrate in which contains34.6g of freeze-dried Khassab powder+ 150g of 0% fat yoghurt
assessing the GI + GL of 50g of Glucose in 100 ml of water
EXPERIMENTAL50g of pure glucose dissolved in 100ml of water
Interventions
Birhi which contain the following: 43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt
34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt
50g of pure glucose dissolved in 100ml of water
Eligibility Criteria
You may qualify if:
- Participants A total of 10 healthy participants aged between 18 and 45 will be recruited through advertisement via poster and flyer. This is an internationally recognised standard protocol which recommends using 10 volunteers or replicates for each foodstuff, and all participants will be required to undergo a screening visit.
You may not qualify if:
- Participants will be considered ineligible to participate in the study if they meet any of the following criteria:
- They have any metabolic diseases such as type 1 or type 2 diabetes.
- They have a BMI above 35kg/m2 or lower than 18kg/m2
- They are taking any illicit or prescribed drugs.
- They are using dietary supplements, over the counter medicine or recreational drugs
- They are females who are pregnant or seeking to become pregnant.
- They have allergies to any food products.
- They have any dairy intolerances.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
December 7, 2018
Study Start
April 16, 2018
Primary Completion
May 31, 2018
Study Completion
June 1, 2018
Last Updated
December 7, 2018
Record last verified: 2018-12