GI Glycaemic Index Healthy VolunteersNCT03769389
Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit
A study testing Birhi and Khassab in people with GI Glycaemic Index Healthy Volunteers and GL Glycaemic Load Healthy Volunteers, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- GI Glycaemic Index Healthy Volunteers, GL Glycaemic Load Healthy Volunteers
- What is being tested?
- Birhi and Khassab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2018to 1 Jun 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
About this study
Official title: Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit When Mixed With 0% Fat Yogurt on Healthy Volunteers.
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.
Read the 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.
- Being tested
- Birhi, Khassab, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirhiDietary supplement
Birhi which contain the following:
43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt
KhassabDietary supplement
34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt
placeboDietary supplement
50g of pure glucose dissolved in 100ml of water
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Birhi; Dietary Supplement: Khassab; Dietary 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 Receives: Dietary Supplement: Birhi; Dietary Supplement: Khassab; Dietary 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 Receives: Dietary Supplement: Birhi; Dietary Supplement: Khassab; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start16 Apr 2018
- Primary completion31 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI Glycaemic Index Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769389
- Sponsor's protocol ID
- DFGI
- Status last verified
- Dec 2018
- First submitted
- 27 Mar 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit When Mixed With 0% Fat Yogurt on Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03769389
- Acronym / sponsor ID
- DFGI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 7 Dec 2018 (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.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| assessing the GI + GL of Birhi + YEO 0% fat yoghurt | Experimental | Dietary Supplement: Birhi, Dietary Supplement: Khassab, Dietary Supplement: placebo47g 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 | Experimental | Dietary Supplement: Birhi, Dietary Supplement: Khassab, Dietary Supplement: placebo47g 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 | Experimental | Dietary Supplement: Birhi, Dietary Supplement: Khassab, Dietary Supplement: placebo50g of pure glucose dissolved in 100ml of water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| BirhiBirhi which contain the following: 43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt | Dietary supplement | assessing the GI + GL of 50g of Glucose in 100 ml of water, assessing the GI + GL of Birhi + YEO 0% fat yoghurt, assessing the GI + GL of Khassab + YEO 0% fat yoghurt |
| Khassab34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt | Dietary supplement | assessing the GI + GL of 50g of Glucose in 100 ml of water, assessing the GI + GL of Birhi + YEO 0% fat yoghurt, assessing the GI + GL of Khassab + YEO 0% fat yoghurt |
| placebo50g of pure glucose dissolved in 100ml of water | Dietary supplement | assessing the GI + GL of 50g of Glucose in 100 ml of water, assessing the GI + GL of Birhi + YEO 0% fat yoghurt, assessing the GI + GL of Khassab + YEO 0% fat yoghurt |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birhi and Khassab in people with GI Glycaemic Index Healthy Volunteers and GL Glycaemic Load Healthy Volunteers, run by Newcastle University at 1 site in United Kingdom.
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 8 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: finished, as of the sponsor's last update on 7 Dec 2018. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 7 Dec 2018.