Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM
NCT ID: NCT06590519
Last Updated: 2024-09-19
Study Results
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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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-07-01
2025-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Date Seed Capsule
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.
Date Seed Extract
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.
Control group: No Intervention
The control group will not receive any capsule ot treatment.
No interventions assigned to this group
Interventions
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Date Seed Extract
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Universiti Putra Malaysia
OTHER
Responsible Party
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Maha Abdulrahman Aldaham
Principal Investigator
Principal Investigators
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Zuriati Ibrahim, PhD
Role: PRINCIPAL_INVESTIGATOR
UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
Locations
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Dr Zuriati Ibrahim
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UPM-PhD MAHA ALDAHAM
Identifier Type: -
Identifier Source: org_study_id
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