Type2 DiabetesNCT04616066
Date Fruit Effects in Type 2 Diabetes
A study testing Dates and Raisins in people with Type2 Diabetes, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.
Trial summary
Dried dates (Phoenix dactylifera) have the second highest phytoestrogen content of any fruit, only secondary to dried apricots with 329ug of phytoestrogens per 100g. The date palm is one of oldest planted trees on the earth at around 2,000 years old. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Dates and Raisins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBahrain
- Study dates
- 10 Oct 2021to 30 May 2022
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of type 2 diabetes will be based on the WHO guidelines. An HbA1C of 6.5% or greater, or 2 fasting plasma glucose readings of >7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meets the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed.
- Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study.
- HbA1c 7.5 - 10%
- Patients between the ages of 45-75 years at the start of the study.
- Capable to give informed consent and complete the study.
Who cannot join
- Patients with concurrent illness or any medication in the last 3 months.
- Patients who are taking hormone replacement therapy.
- Patients who are currently or have taken antibiotics in the last 3 months.
- Currently enrolled in other clinical trials.
- Hba1c at recruiting stage of more than 10%.
- Patients with a BMI less than 20 and more than 40.
Show all 10Show fewer
- Patients with known food allergies.
- Patients on insulin.
- Patients who are eating dates or raisins should be washed out for 4 weeks.
- Pregnant or nursing, or plans to become pregnant in the next 3 months, or not using adequate contraceptive measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Date Fruit Phytoestrogen on the Glycemic Control of Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Dried dates (Phoenix dactylifera) have the second highest phytoestrogen content of any fruit, only secondary to dried apricots with 329ug of phytoestrogens per 100g. The date palm is one of oldest planted trees on the earth at around 2,000 years old. Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies. Date sugars have also been shown to be phenol rich, potent antioxidant, and strong inhibitor of α -glycosidase that may also have benefit in diabetes. In addition, dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance . Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes.
The objective of this study is to investigate the effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes in comparison to the same glycemic load of raisins that have low phytoestrogen content.
Read the detailed description
Production and consumption of soy foods within Western countries have increased dramatically in the last decade with the postulated health benefits including improvement in bone health, relief of menopausal symptoms and reduced risk of certain types of cancers due to the soy phytoestrogens. In addition, habitual intake of soy phytoestrogens has also been associated with a reduced risk of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), which is of particular relevance given the increasing global prevalence of diabetes. This is a particular problem here in the Middle East and North Africa (MENA) region, where diabetes is considered as a serious and increasing health problem. According to the International Diabetes Federation the prevalence of diabetes in the MENA region is over 23.3%; however worldwide there is an epidemic increase in type 2 diabetes with the WHO report that approximately 415 million people have diabetes worldwide, and that by 2030, diabetes will be the 7th leading cause of death.
Dried dates (Phoenix dactylifera) have the second highest phytoestrogen content of any fruit, only secondary to dried apricots with 329ug of phytoestrogens per 100g. The date palm is one of oldest planted trees on the earth at around 2,000 years old. Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies. Date sugars have also been shown to be phenol rich, potent antioxidant, and strong inhibitor of α -glycosidase that may also have benefit in diabetes. In addition, dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance. Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes.
There has not been a medium term study of the effect of date fruit in diabetes; therefore, this study will determine if the consumption Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g), in accord with that advised in the Holy Qur'an, will improve the glycemic control in men with type 2 diabetes, in comparison with the equivalent glycemic load of raisins (30g twice daily, phytoestrogen content of 9.6ug/100g). Each intervention will be taken as a snack mid-morning and mid-afternoon.
- Conditions
- Type2 Diabetes
- Being tested
- Dates, Raisins
- Keywords
- Type2 diabetes, Dates, Phytoestrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DatesOther
The effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
RaisinsOther
The effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Dates Arm | Experimental | Consumption of Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g) Receives: Other: Dates |
| Raisins Arm | Experimental | Consumption of Raisins (30g twice daily, phytoestrogen content of 9.6ug/100g) Receives: Other: Raisins |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
Measuring the levels of phytoestrogen and evaluate if it has reduced the average blood sugar levels over a period of 3 months.
Measured: 90 days
Secondary outcomes (2)
Determine whether date phytoestrogens affect cardiovascular risk
Determine whether the level of phytoestrogens has lowered risks of cardiovascular disease by measuring the fasting lipids, C reactive protein and blood pressure.
Measured: 90 days
Determine whether date phytoestrogens affect insulin resistance
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel, prospective, interventional and randomized trial involving 80 patients with type 2 diabetes. They will be randomised to either 60g of dates or 60g of raisins (amount split and given as a mid-morning and mid-afternoon snack) for 3 months.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons in Ireland - Medical University of Bahrain
- Sponsor type
- University, hospital or other
- Collaborators
- King Hamad University Hospital, Bahrain
- Responsible party
- Sponsor
- Investigators
- Naji Alamuddin, Dr., Principal investigator, Royal College of Surgeons in Ireland - Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616066
- Sponsor's protocol ID
- 89 / 25-Oct-2020
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Publications
Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008 Jun;138(6):1244S-9S. doi: 10.1093/jn/138.6.1244S.
PubMed 18492864Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.
PubMed 12351466Xu SZ, Zeng B, Daskoulidou N, Chen GL, Atkin SL, Lukhele B. Activation of TRPC cationic channels by mercurial compounds confers the cytotoxicity of mercury exposure. Toxicol Sci. 2012 Jan;125(1):56-68. doi: 10.1093/toxsci/kfr268. Epub 2011 Oct 9.
PubMed 21984481Thompson LU, Boucher BA, Liu Z, Cotterchio M, Kreiger N. Phytoestrogen content of foods consumed in Canada, including isoflavones, lignans, and coumestan. Nutr Cancer. 2006;54(2):184-201. doi: 10.1207/s15327914nc5402_5.
PubMed 16898863Vayalil PK. Date fruits (Phoenix dactylifera Linn): an emerging medicinal food. Crit Rev Food Sci Nutr. 2012;52(3):249-71. doi: 10.1080/10408398.2010.499824.
PubMed 22214443Hamad I, AbdElgawad H, Al Jaouni S, Zinta G, Asard H, Hassan S, Hegab M, Hagagy N, Selim S. Metabolic Analysis of Various Date Palm Fruit (Phoenix dactylifera L.) Cultivars from Saudi Arabia to Assess Their Nutritional Quality. Molecules. 2015 Jul 27;20(8):13620-41. doi: 10.3390/molecules200813620.
PubMed 26225946Alkaabi JM, Al-Dabbagh B, Ahmad S, Saadi HF, Gariballa S, Ghazali MA. Glycemic indices of five varieties of dates in healthy and diabetic subjects. Nutr J. 2011 May 28;10:59. doi: 10.1186/1475-2891-10-59.
PubMed 21619670Alkaabi J, Al-Dabbagh B, Saadi H, Gariballa S, Yasin J. Effect of traditional Arabic coffee consumption on the glycemic index of Khalas dates tested in healthy and diabetic subjects. Asia Pac J Clin Nutr. 2013;22(4):565-73. doi: 10.6133/apjcn.2013.22.4.09.
PubMed 24231017Miller CJ, Dunn EV, Hashim IB. The glycaemic index of dates and date/yoghurt mixed meals. Are dates 'the candy that grows on trees'? Eur J Clin Nutr. 2003 Mar;57(3):427-30. doi: 10.1038/sj.ejcn.1601565.
PubMed 12627179Senn SJ. Covariate imbalance and random allocation in clinical trials. Stat Med. 1989 Apr;8(4):467-75. doi: 10.1002/sim.4780080410.
PubMed 2727470Senn S. Testing for baseline balance in clinical trials. Stat Med. 1994 Sep 15;13(17):1715-26. doi: 10.1002/sim.4780131703.
PubMed 7997705Knol MJ, Groenwold RH, Grobbee DE. P-values in baseline tables of randomised controlled trials are inappropriate but still common in high impact journals. Eur J Prev Cardiol. 2012 Apr;19(2):231-2. doi: 10.1177/1741826711421688. No abstract available.
PubMed 22512015
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Date Fruit Phytoestrogen on the Glycemic Control of Patients With Type 2 Diabetes: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04616066
- Acronym / sponsor ID
- 89 / 25-Oct-2020
- Conditions
- Type2 Diabetes
- Keywords
- Type2 diabetes, Dates, Phytoestrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Royal College of Surgeons in Ireland - Medical University of BahrainUniversity, hospital or other
- Collaborators
- King Hamad University Hospital, Bahrain
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 4 Nov 2020 (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.
Dried dates (Phoenix dactylifera) have the second highest phytoestrogen content of any fruit, only secondary to dried apricots with 329ug of phytoestrogens per 100g. The date palm is one of oldest planted trees on the earth at around 2,000 years old. Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies. Date sugars have also been shown to be phenol rich, potent antioxidant, and strong inhibitor of α -glycosidase that may also have benefit in diabetes. In addition, dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance . Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes.
The objective of this study is to investigate the effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes in comparison to the same glycemic load of raisins that have low phytoestrogen content.
Detailed description
Production and consumption of soy foods within Western countries have increased dramatically in the last decade with the postulated health benefits including improvement in bone health, relief of menopausal symptoms and reduced risk of certain types of cancers due to the soy phytoestrogens. In addition, habitual intake of soy phytoestrogens has also been associated with a reduced risk of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), which is of particular relevance given the increasing global prevalence of diabetes. This is a particular problem here in the Middle East and North Africa (MENA) region, where diabetes is considered as a serious and increasing health problem. According to the International Diabetes Federation the prevalence of diabetes in the MENA region is over 23.3%; however worldwide there is an epidemic increase in type 2 diabetes with the WHO report that approximately 415 million people have diabetes worldwide, and that by 2030, diabetes will be the 7th leading cause of death.
Dried dates (Phoenix dactylifera) have the second highest phytoestrogen content of any fruit, only secondary to dried apricots with 329ug of phytoestrogens per 100g. The date palm is one of oldest planted trees on the earth at around 2,000 years old. Dates are nutritionally rich and a good source of fiber and carbohydrates and their potential medicinal and nutritional effects have been suggested in a number of studies. Date sugars have also been shown to be phenol rich, potent antioxidant, and strong inhibitor of α -glycosidase that may also have benefit in diabetes. In addition, dates are rich in micronutrients that may also have benefit for diabetes and insulin resistance. Dates have a glycemic index of 50 and studies have shown that the consumption of differing varieties of dates do not significantly affect the acute glycemia in patients with type 2 diabetes.
There has not been a medium term study of the effect of date fruit in diabetes; therefore, this study will determine if the consumption Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g), in accord with that advised in the Holy Qur'an, will improve the glycemic control in men with type 2 diabetes, in comparison with the equivalent glycemic load of raisins (30g twice daily, phytoestrogen content of 9.6ug/100g). Each intervention will be taken as a snack mid-morning and mid-afternoon.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel, prospective, interventional and randomized trial involving 80 patients with type 2 diabetes. They will be randomised to either 60g of dates or 60g of raisins (amount split and given as a mid-morning and mid-afternoon snack) for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Dates Arm | Experimental | Other: DatesConsumption of Khalas dates (3 dates =30g undried dates) twice daily (phytoestrogen content 329ug/100g) |
| Raisins Arm | Experimental | Other: RaisinsConsumption of Raisins (30g twice daily, phytoestrogen content of 9.6ug/100g) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The diagnosis of type 2 diabetes will be based on the WHO guidelines. An HbA1C of 6.5% or greater, or 2 fasting plasma glucose readings of >7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meets the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed.
- Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study.
- HbA1c 7.5 - 10%
- Patients between the ages of 45-75 years at the start of the study.
- Capable to give informed consent and complete the study.
Key exclusion criteria (10 listed)
- Patients with concurrent illness or any medication in the last 3 months.
- Patients who are taking hormone replacement therapy.
- Patients who are currently or have taken antibiotics in the last 3 months.
- Currently enrolled in other clinical trials.
- Hba1c at recruiting stage of more than 10%.
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 |
|---|---|---|
| DatesThe effect of date phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes | Other | Dates Arm |
| RaisinsThe effect of raisins phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes | Other | Raisins Arm |
Primary outcome
The effect of phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes
Time frame: 90 days
Measuring the levels of phytoestrogen and evaluate if it has reduced the average blood sugar levels over a period of 3 months.
2 secondary outcomes
Determine whether date phytoestrogens affect cardiovascular risk
Time frame: 90 days
Determine whether date phytoestrogens affect insulin resistance
Time frame: 90 days
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 4 Oct 2022.
- Background: PubMed 18492864Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008 Jun;138(6):1244S-9S. doi: 10.1093/jn/138.6.1244S.
- Background: PubMed 12351466Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.
- Background: PubMed 21984481Xu SZ, Zeng B, Daskoulidou N, Chen GL, Atkin SL, Lukhele B. Activation of TRPC cationic channels by mercurial compounds confers the cytotoxicity of mercury exposure. Toxicol Sci. 2012 Jan;125(1):56-68. doi: 10.1093/toxsci/kfr268. Epub 2011 Oct 9.
- Background: PubMed 16898863Thompson LU, Boucher BA, Liu Z, Cotterchio M, Kreiger N. Phytoestrogen content of foods consumed in Canada, including isoflavones, lignans, and coumestan. Nutr Cancer. 2006;54(2):184-201. doi: 10.1207/s15327914nc5402_5.
- Background: PubMed 22214443Vayalil PK. Date fruits (Phoenix dactylifera Linn): an emerging medicinal food. Crit Rev Food Sci Nutr. 2012;52(3):249-71. doi: 10.1080/10408398.2010.499824.
- Background: PubMed 26225946Hamad I, AbdElgawad H, Al Jaouni S, Zinta G, Asard H, Hassan S, Hegab M, Hagagy N, Selim S. Metabolic Analysis of Various Date Palm Fruit (Phoenix dactylifera L.) Cultivars from Saudi Arabia to Assess Their Nutritional Quality. Molecules. 2015 Jul 27;20(8):13620-41. doi: 10.3390/molecules200813620.
- Background: PubMed 21619670Alkaabi JM, Al-Dabbagh B, Ahmad S, Saadi HF, Gariballa S, Ghazali MA. Glycemic indices of five varieties of dates in healthy and diabetic subjects. Nutr J. 2011 May 28;10:59. doi: 10.1186/1475-2891-10-59.
- Background: PubMed 24231017Alkaabi J, Al-Dabbagh B, Saadi H, Gariballa S, Yasin J. Effect of traditional Arabic coffee consumption on the glycemic index of Khalas dates tested in healthy and diabetic subjects. Asia Pac J Clin Nutr. 2013;22(4):565-73. doi: 10.6133/apjcn.2013.22.4.09.
- Background: PubMed 12627179Miller CJ, Dunn EV, Hashim IB. The glycaemic index of dates and date/yoghurt mixed meals. Are dates 'the candy that grows on trees'? Eur J Clin Nutr. 2003 Mar;57(3):427-30. doi: 10.1038/sj.ejcn.1601565.
- Background: PubMed 2727470Senn SJ. Covariate imbalance and random allocation in clinical trials. Stat Med. 1989 Apr;8(4):467-75. doi: 10.1002/sim.4780080410.
- Background: PubMed 7997705Senn S. Testing for baseline balance in clinical trials. Stat Med. 1994 Sep 15;13(17):1715-26. doi: 10.1002/sim.4780131703.
- Background: PubMed 22512015Knol MJ, Groenwold RH, Grobbee DE. P-values in baseline tables of randomised controlled trials are inappropriate but still common in high impact journals. Eur J Prev Cardiol. 2012 Apr;19(2):231-2. doi: 10.1177/1741826711421688. No abstract available.
- Individual participant dataSharing planned: Yes. Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Related trials for Type2 Diabetes
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
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.
Naji Alamuddin, Dr. principal investigator
Royal College of Surgeons in Ireland - Bahrain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dates and Raisins in people with Type2 Diabetes, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.
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 5 inclusion and 10 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 4 Oct 2022. 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 Bahrain. 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?
The effect of phytoestrogens on HbA1C and fasting blood glucose in patients with type 2 diabetes (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616066, which also lists 12 linked publications.
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 4 Oct 2022.