RecruitingNot ApplicableNCT06590519

Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM

The Effectiveness of Date Seed Extract in Controlling Diabetes and Reducing Cardiovascular Risk in Patients With Type 2 Diabetes in Riyadh, Saudi Arabia


Sponsor

Universiti Putra Malaysia

Enrollment

160 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

Interventions

OTHERDate 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.


Locations(1)

Dr Zuriati Ibrahim

Serdang, Selangor, Malaysia

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NCT06590519


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