NCT03769389

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

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

March 27, 2018

Last Update Submit

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

EXPERIMENTAL

47g of total carbohydrate in which contains 43.6g of Freeze-dried of Birhi powder+ 150g of 0% fat yoghurt

Dietary Supplement: BirhiDietary Supplement: KhassabDietary Supplement: placebo

assessing the GI + GL of Khassab + YEO 0% fat yoghurt

EXPERIMENTAL

47g of total carbohydrate in which contains34.6g of freeze-dried Khassab powder+ 150g of 0% fat yoghurt

Dietary Supplement: BirhiDietary Supplement: KhassabDietary Supplement: placebo

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

EXPERIMENTAL

50g of pure glucose dissolved in 100ml of water

Dietary Supplement: BirhiDietary Supplement: KhassabDietary Supplement: placebo

Interventions

BirhiDIETARY_SUPPLEMENT

Birhi which contain the following: 43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt

assessing the GI + GL of 50g of Glucose in 100 ml of waterassessing the GI + GL of Birhi + YEO 0% fat yoghurtassessing the GI + GL of Khassab + YEO 0% fat yoghurt
KhassabDIETARY_SUPPLEMENT

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

assessing the GI + GL of 50g of Glucose in 100 ml of waterassessing the GI + GL of Birhi + YEO 0% fat yoghurtassessing the GI + GL of Khassab + YEO 0% fat yoghurt
placeboDIETARY_SUPPLEMENT

50g of pure glucose dissolved in 100ml of water

assessing the GI + GL of 50g of Glucose in 100 ml of waterassessing the GI + GL of Birhi + YEO 0% fat yoghurtassessing the GI + GL of Khassab + YEO 0% fat yoghurt

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations