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Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit

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ClinicalTrials.gov Identifier: NCT03769389
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Newcastle University

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.


Condition or disease Intervention/treatment Phase
GI Glycaemic Index Healthy Volunteers GL Glycaemic Load Healthy Volunteers Dietary Supplement: Birhi Dietary Supplement: Khassab Dietary Supplement: placebo Not Applicable

Detailed Description:

Introduction Although, the fruit of the date palm (P. dactylifera) may be considered an emerging and potential candidate for the development of health-promoting foods owing to its high nutritive values,the high sugar content of date fruit has always been a concern. Sun-dried dates, which is the well-known ripening stage of date fruit, can be regarded as low-GI to medium-GI food. However, very limited, inconsistent and contradictory information is available on the glycaemic Index values of different date varieties. This variation could be attributed to either the methodology or the food factors.

Rational and objective Nowadays, low-GI foods have often been found to induce beneficial effects on risk factors for certain non-communicable chronic diseases . As the chemical composition of dates can vary depending on cultivar, soil conditions, agronomic practices as well as the ripening stage. It is important to know the GI of the local/regional date varieties, and in different date products such as dates with yoghurt. Date consumption is high among people of Arabic origin, where it is very commonly eaten with coffee or yoghurt. During the first trial of this PHD project, treatments containing 150g of 0% fat yoghurt and two different freeze dried date powders, depending on if it was a Birhi treatment or Khassab treatment, were formulated. These were used to assess acute effects of date fruit and yoghurt on mood and cognitive performance in healthy volunteers, as per the ethical approval from Newcastle University. These exact treatments will be used again, and the trial will aim to evaluate their glycaemic index on 10 healthy participants.

Participants Ten healthy participants aged between 18 and 45 will be recruited. Participants will be required to undergo a screening visit, followed by three study visits, which will last 2:15 minutes for each visit. Glycaemic indexes will be calculated using standard methods. Results will be calculated using means and standard deviations.

Design

A standard experimental study involving the measurement of the glycaemic responses of the ingestion of two different varieties of dates, when mixed with 0% fat yoghurt, and a placebo treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit When Mixed With 0% Fat Yogurt on Healthy Volunteers.
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 1, 2018

Arm Intervention/treatment
Experimental: assessing the GI + GL of Birhi + YEO 0% fat yoghurt
47g of total carbohydrate in which contains 43.6g of Freeze-dried of Birhi powder+ 150g of 0% fat yoghurt
Dietary Supplement: Birhi

Birhi which contain the following:

43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt


Dietary Supplement: Khassab
34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

Dietary Supplement: placebo
50g of pure glucose dissolved in 100ml of water

Experimental: assessing the GI + GL of Khassab + YEO 0% fat yoghurt
47g of total carbohydrate in which contains34.6g of freeze-dried Khassab powder+ 150g of 0% fat yoghurt
Dietary Supplement: Birhi

Birhi which contain the following:

43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt


Dietary Supplement: Khassab
34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

Dietary Supplement: placebo
50g of pure glucose dissolved in 100ml of water

Experimental: assessing the GI + GL of 50g of Glucose in 100 ml of water
50g of pure glucose dissolved in 100ml of water
Dietary Supplement: Birhi

Birhi which contain the following:

43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt


Dietary Supplement: Khassab
34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

Dietary Supplement: placebo
50g of pure glucose dissolved in 100ml of water




Primary Outcome Measures :
  1. Blood glucose concentrations (mml/15 min)after the consumption Birhi [ Time Frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose ]
    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.

  2. Blood glucose concentrations (mml/15 min)after the consumption Khassab [ Time Frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose ]
    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.

  3. Blood glucose concentrations (mml/15 min)after the consumption Placebo [ Time Frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Inclusion Criteria Healthy participants aged 18-45 with a BMI >18 <36 will be recruited from the Newcastle Upon-Tyne area.

Exclusion Criteria:

Participants will be considered ineligible to participate in the study if they meet any of the following criteria:

  1. They have any metabolic diseases such as type 1 or type 2 diabetes.
  2. They have a BMI above 35kg/m2 or lower than 18kg/m2
  3. They are taking any illicit or prescribed drugs.
  4. They are using dietary supplements, over the counter medicine or recreational drugs
  5. They are females who are pregnant or seeking to become pregnant.
  6. They have allergies to any food products.
  7. They have any dairy intolerances.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769389


Locations
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United Kingdom
NU-Food Research Facility
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 7RU
Sponsors and Collaborators
Newcastle University

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Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03769389     History of Changes
Other Study ID Numbers: DFGI
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No