Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06590519

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes Mellitus, Obesity

Full registry 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.

Treatments and study arms

Date Seed Extract

Other

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.

Primary outcomes

Change in Blood Glucose Levels[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: 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: 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Dr Zuriati Ibrahim🇲🇾 Serdang, Selangor, Malaysia

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Dr Zuriati Ibrahim, PhDContact

Email · Call +603-97692464

Maha Aldaham, MasterContact

Email · Call +60176652101