Clinical trial NCT06590519: Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT)
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Blood Glucose Levels
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
measure: Change in cholesterol Levels
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
measure: Change in Blood Pressure
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Secondary outcomes:
measure: Change the Body mass index (BMI)
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
measure: Change in Change in physical activity
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
measure: Change in daytime sleepiness
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
measure: Change in dietary intakes
timeFrame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Dr Zuriati Ibrahim
state: Selangor
Study officials:
affiliation: UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia
name: Zuriati Ibrahim, PhD
role: PRINCIPAL_INVESTIGATOR
References: