Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit

NCT ID: NCT03769389

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2018-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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GI Glycaemic Index Healthy Volunteers GL Glycaemic Load Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Birhi

Intervention Type DIETARY_SUPPLEMENT

Birhi which contain the following:

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

Khassab

Intervention Type DIETARY_SUPPLEMENT

34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

placebo

Intervention Type DIETARY_SUPPLEMENT

50g of pure glucose dissolved in 100ml of water

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

Group Type EXPERIMENTAL

Birhi

Intervention Type DIETARY_SUPPLEMENT

Birhi which contain the following:

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

Khassab

Intervention Type DIETARY_SUPPLEMENT

34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

placebo

Intervention Type DIETARY_SUPPLEMENT

50g of pure glucose dissolved in 100ml of water

assessing the GI + GL of 50g of Glucose in 100 ml of water

50g of pure glucose dissolved in 100ml of water

Group Type EXPERIMENTAL

Birhi

Intervention Type DIETARY_SUPPLEMENT

Birhi which contain the following:

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

Khassab

Intervention Type DIETARY_SUPPLEMENT

34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

placebo

Intervention Type DIETARY_SUPPLEMENT

50g of pure glucose dissolved in 100ml of water

Interventions

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Birhi

Birhi which contain the following:

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

Intervention Type DIETARY_SUPPLEMENT

Khassab

34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt

Intervention Type DIETARY_SUPPLEMENT

placebo

50g of pure glucose dissolved in 100ml of water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NU-Food Research Facility

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DFGI

Identifier Type: -

Identifier Source: org_study_id