Type 2 Diabetes MellitusNCT06590519
Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM
A study testing Date Seed Extract in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Globally, chronic noncommunicable diseases rank as the leading cause of morbidity and mortality. Diabetes is reaching high epidemic proportions across the globe. The prevalence of diabetes is increasing in Saudi Arabia, with diabetes affecting 14.1% of the population across all age groups and 28% of those over the age… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Date Seed Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2024to 30 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years old and above.
- Diagnosis of Type 2 diabetes.
- Receiving and monitoring diabetes care from diabetes center.
- With stable HbA1c less than 10% (no episode of hypoglycaemia, no hospitalisation, no change in type or dosage of medication use for at least 6 months).
Who cannot join
- Pregnant or lactating women.
- Diagnosis of cardiac failure or/and severe renal disease, with physical or mental disability, neurological or cognitive impairment.
- Participant with severely impaired vision, hearing, or speech.
- Participants who have known allergy to dates products.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Dr Zuriati Ibrahim
Serdang, Selangor, 43400
Dr Zuriati Ibrahim, PhD, +603-97692464, zuriatiib@upm.edu.my
Maha Aldaham, Master, +60176652101, maaaldaham8@gmail.com
About this study
Official title: The Effectiveness of Date Seed Extract in Controlling Diabetes and Reducing Cardiovascular Risk in Patients With Type 2 Diabetes in Riyadh, Saudi Arabia
Globally, chronic noncommunicable diseases rank as the leading cause of morbidity and mortality. Diabetes is reaching high epidemic proportions across the globe. The prevalence of diabetes is increasing in Saudi Arabia, with diabetes affecting 14.1% of the population across all age groups and 28% of those over the age of 30. Date seed intake is one of the best-studied patterns. Previous studies findinds showed that the phenolic compounds in date seeds have blood sugar-lowering properties. There is a lack of data on how date seed diets may affect glycaemia control and cardiovascular risk among Saudi Arabian patients with T2DM. Therefore, randomised controlled trials (RCTs) will be conducted to assess the effects of date seeds on glycaemic control and cardiovascular risk among diabetes patients.
Read the detailed description
A randomized controlled trial study will be conducted among adults with Type 2 diabetes who referred to the diabetes center to optimise dietary intervention for diabetes control in King Fahad Medical City (KFMC), Riyadh, Saudi Arabia. A total of 160 participants (80 participants for each group) will be select using simple random sampling.
The intervention group will receive a capsule of date-seed powder, while the control group will not receive any capsule. Each person should consume 5 grams (two capsules of date-seed powder) twice daily after meals for three months. Assessments are carried out at the beginning of the study, one month and two months after the intervention (Chan et al., 2013). Participants will be contacted twice a week to ensure that they are adhering to the rules, maintaining their physical activity and clarifying any questions about taking supplements. A checklist is also provided to all participants to monitor their adherence. Participants who fail to take more than 10% of the packs will be excluded from the study.
For the preparation of date seeds (Sukkari), firstly the desired concentrations of date seed powder for the different versions of Sukkari are determined. Secondly, the amount of date seed powder required for each concentration is calculated based on the total volume of the product. Then, separate containers are prepared for each version of Sukkari. A grinder is used to extract the bioactive substances from the date seeds and prepare the powder. First, the date seeds are washed and dried. Then we use a grinder and grind them into powder. Finally, gelatin capsules will be filled with date kernel powder, and then packed in identical containers.
The data will be collected from the intervention and control group before the intervention, one month after the intervention and two months follow-up after the intervention data collection through a self-administered questionnaire. The questionnaire will be consisted of eight sections aimed at obtaining information on socio-demographic data, lifestyle characteristics and clinical parameters of the study participants. Accordingly, dietary data and physical measurements, including anthropometric measurements, blood pressure and biochemical parameters, will be collected. Data will be analyzed by using the software Statistical Package for Social Sciences (SPSS) version 26.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Date Seed Extract
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date Seed ExtractOther
Also called Intervention group
Intervention group participants will undergo a three-month intervention program. The Health Belief Model (HBM) will be the underlying theory to facilitate behaviour change.
The intervention group will receive a capsule of date-seed-powder. Each person should consume 5 grams (two capsules of date-seed powder)twice daily after meals for three months.
Assessments are carried out at the beginning of the study, one month and two months after the intervention on the effect of date-seed on glycaemic control,risk of cardiovascular, physical activity, daytime sleepiness and anthropometric measurements. Participants will be contacted twice a week to ensure that they are adhering to the rules.
| Study group | Role | What they receive |
|---|---|---|
| Date Seed Capsule | Other | The intervention group will receive a capsule of date-seed powder. Each person should consume 5 grams (two capsules of date-seed powder) twice daily after meals for three months. Assessments are carried out at the beginning of the study, one month and two months after the intervention (Chan et al., 2013). Participants will be contacted twice a week to ensure that they are adhering to the rules, maintaining their physical activity and clarifying any questions about taking supplements. Receives: Other: Date Seed Extract |
| Control group: No Intervention | No intervention | The control group will not receive any capsule ot treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose Levels
Fasting plasma glucose and Random blood glucose will be measured using a spectrophotometer. The normal range of the Fasting plasma glucose is (5.6 - 6.9 mmol/l) and for Random blood glucose is (7.8-11.0 mmol/l).
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in cholesterol Levels
Total cholesterol includes both High density lipoprotein cholesterol (HDL) and Low density lipoprotein cholesterol (LDL) will be measured using a spectrophotometer. The normal range of the total cholesterol is (≤ 5.2 mmol/l). While the normal range of LDL-cholesterol is (˂ 2.6 mmol/l) and HDL-cholesterol is (˃ 1.3 mmol/l)
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in Blood Pressure
Blood pressure will be measured using sphygmomanometer. Normal blood pressure is usually considered to be between 120/80 mmHg.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Secondary outcomes (4)
Change the Body mass index (BMI)
The Body mass index (BMI) will be report in kg/m^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared). Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg. SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm. Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity). If the BMI is less than 18.5, it falls within the underweight range. If the BMI is 18.5 to <25, it falls within the healthy weight range. If the BMI is 25.0 to <30, it falls within the overweight range. If the BMI is 30.0 or higher, it falls within the obesity range.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in Change in physical activity
Physical activity practice will be measured using international physical activity questionnaire (IPAQ). Time spent on all physical activity types will be summed to obtain each physical activity type's time spent per week. Frequency, duration, and intensity for each physical activity type were coded into metabolic equivalent (MET) tables. The total MET per week for all physical activities was calculated by multiplying the duration (minutes) of activity per week by its corresponding METs and summing for each physical activity type. Sufficient MET was defined as ≥600 METs per week.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in daytime sleepiness
Participants' daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). Participants will be asked to rate their chances of dozing during certain daily activities using ratings range from 0 (never doze) to 3 (high chance of dozing). Scores range from 0 to 24. An ESS score greater than 10 indicates excessive daytime sleepiness.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in dietary intakes
The 24-hour dietary recall will be used at baseline and at the end of the study to assess participants' dietary intake on two non-consecutive days (one usual day and one weekend day).
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Randomized Controlled Trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abdulrahman Aldaham, Universiti Putra Malaysia
- Investigators
- Zuriati Ibrahim, PhD, Principal investigator, UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590519
- Sponsor's protocol ID
- UPM-PhD MAHA ALDAHAM
- Status last verified
- Sep 2024
- First submitted
- 6 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Date Seed Extract in Controlling Diabetes and Reducing Cardiovascular Risk in Patients With Type 2 Diabetes in Riyadh, Saudi Arabia
- ClinicalTrials.gov ID
- NCT06590519
- Acronym / sponsor ID
- UPM-PhD MAHA ALDAHAM
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Globally, chronic noncommunicable diseases rank as the leading cause of morbidity and mortality. Diabetes is reaching high epidemic proportions across the globe. The prevalence of diabetes is increasing in Saudi Arabia, with diabetes affecting 14.1% of the population across all age groups and 28% of those over the age of 30. Date seed intake is one of the best-studied patterns. Previous studies findinds showed that the phenolic compounds in date seeds have blood sugar-lowering properties. There is a lack of data on how date seed diets may affect glycaemia control and cardiovascular risk among Saudi Arabian patients with T2DM. Therefore, randomised controlled trials (RCTs) will be conducted to assess the effects of date seeds on glycaemic control and cardiovascular risk among diabetes patients.
Detailed description
A randomized controlled trial study will be conducted among adults with Type 2 diabetes who referred to the diabetes center to optimise dietary intervention for diabetes control in King Fahad Medical City (KFMC), Riyadh, Saudi Arabia. A total of 160 participants (80 participants for each group) will be select using simple random sampling.
The intervention group will receive a capsule of date-seed powder, while the control group will not receive any capsule. Each person should consume 5 grams (two capsules of date-seed powder) twice daily after meals for three months. Assessments are carried out at the beginning of the study, one month and two months after the intervention (Chan et al., 2013). Participants will be contacted twice a week to ensure that they are adhering to the rules, maintaining their physical activity and clarifying any questions about taking supplements. A checklist is also provided to all participants to monitor their adherence. Participants who fail to take more than 10% of the packs will be excluded from the study.
For the preparation of date seeds (Sukkari), firstly the desired concentrations of date seed powder for the different versions of Sukkari are determined. Secondly, the amount of date seed powder required for each concentration is calculated based on the total volume of the product. Then, separate containers are prepared for each version of Sukkari. A grinder is used to extract the bioactive substances from the date seeds and prepare the powder. First, the date seeds are washed and dried. Then we use a grinder and grind them into powder. Finally, gelatin capsules will be filled with date kernel powder, and then packed in identical containers.
The data will be collected from the intervention and control group before the intervention, one month after the intervention and two months follow-up after the intervention data collection through a self-administered questionnaire. The questionnaire will be consisted of eight sections aimed at obtaining information on socio-demographic data, lifestyle characteristics and clinical parameters of the study participants. Accordingly, dietary data and physical measurements, including anthropometric measurements, blood pressure and biochemical parameters, will be collected. Data will be analyzed by using the software Statistical Package for Social Sciences (SPSS) version 26.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Date Seed Capsule | Other | Other: Date Seed ExtractThe intervention group will receive a capsule of date-seed powder. Each person should consume 5 grams (two capsules of date-seed powder) twice daily after meals for three months. Assessments are carried out at the beginning of the study, one month and two months after the intervention (Chan et al., 2013). Participants will be contacted twice a week to ensure that they are adhering to the rules, maintaining their physical activity and clarifying any questions about taking supplements. |
| Control group: No Intervention | No intervention | –The control group will not receive any capsule ot treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years old and above.
- Diagnosis of Type 2 diabetes.
- Receiving and monitoring diabetes care from diabetes center.
- With stable HbA1c less than 10% (no episode of hypoglycaemia, no hospitalisation, no change in type or dosage of medication use for at least 6 months).
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Diagnosis of cardiac failure or/and severe renal disease, with physical or mental disability, neurological or cognitive impairment.
- Participant with severely impaired vision, hearing, or speech.
- Participants who have known allergy to dates products.
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 |
|---|---|---|
| Date Seed ExtractAlso: Intervention groupIntervention group participants will undergo a three-month intervention program. The Health Belief Model (HBM) will be the underlying theory to facilitate behaviour change. The intervention group will receive a capsule of date-seed-powder. Each person should consume 5 grams (two capsules of date-seed powder)twice daily after meals for three months. Assessments are carried out at the beginning of the study, one month and two months after the intervention on the effect of date-seed on glycaemic control,risk of cardiovascular, physical activity, daytime sleepiness and anthropometric measurements. Participants will be contacted twice a week to ensure that they are adhering to the rules. | Other | Date Seed Capsule |
Primary outcome
Change in Blood Glucose Levels
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Fasting plasma glucose and Random blood glucose will be measured using a spectrophotometer. The normal range of the Fasting plasma glucose is (5.6 - 6.9 mmol/l) and for Random blood glucose is (7.8-11.0 mmol/l).
Change in cholesterol Levels
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Total cholesterol includes both High density lipoprotein cholesterol (HDL) and Low density lipoprotein cholesterol (LDL) will be measured using a spectrophotometer. The normal range of the total cholesterol is (≤ 5.2 mmol/l). While the normal range of LDL-cholesterol is (˂ 2.6 mmol/l) and HDL-cholesterol is (˃ 1.3 mmol/l)
Change in Blood Pressure
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Blood pressure will be measured using sphygmomanometer. Normal blood pressure is usually considered to be between 120/80 mmHg.
4 secondary outcomes
Change the Body mass index (BMI)
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in Change in physical activity
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in daytime sleepiness
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Change in dietary intakes
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Zuriati Ibrahim, PhD principal investigator
UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Date Seed Extract in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Aldaham, Master (+60176652101, maaaldaham8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Glucose Levels (time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]). 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 19 Sep 2024.