Date Seed Extract Effectiveness in Controlling Diabetes and Cardiovascular Risk in T2DM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversiti Putra Malaysia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Date Seed Extract
Other interventionIntervention 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Date Seed CapsuleOther 1 intervention
Group B: Control group: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]2
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)
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]3
Change in Blood Pressure
Blood pressure will be measured using sphygmomanometer. Normal blood pressure is usually considered to be between 120/80 mmHg.
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]Secondary outcomes
1
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.
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]2
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.
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]3
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.
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]4
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).
Time frame
[Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]Sponsors and contacts
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Source ClinicalTrials.gov