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

NCT06590519 | Recruiting

• 1 other identifier: UPM-PhD MAHA ALDAHAM
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (3)

• 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: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

• 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: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

• 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: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

Secondary Outcomes (4)

• Change the Body mass index (BMI)

  [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

• Change in Change in physical activity

  [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

• Change in daytime sleepiness

  [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

• Change in dietary intakes

  [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (12-week post intervention)]

Study Arms (2)

Date Seed Capsule

OTHER

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.

Other: Date Seed Extract

Control group: No Intervention

NO INTERVENTION

The control group will not receive any capsule ot treatment.

Interventions

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.

Also known as: Intervention group

Date Seed Capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Dr Zuriati Ibrahim

Serdang, Selangor, 43400, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zuriati Ibrahim, PhD

  UniversitI Putra Malaysia (UPM), 43400 Serdang, Selangor, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Aldaham, Master

CONTACT

+60176652101; maaaldaham8@gmail.com

Zuriati Ibrahim, PhD

CONTACT

+603-97692464; zuriatiib@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participants)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)