The goal of this interventional Randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of Iraqi participants. The main questions to answer are: 1. What are the effects of the tested regimens on the level of IL-1 and IL-15. 2. What are the effects of the tested regimens on the Fasting Blood glucose? 3. What are the effects of the tested regimens on the HbA1C? 4. What are the effects of the tested regimens on the Body Mass Index? 5. What are the effects of the tested regimens on the Lipid profile? 6. What are the effects of the tested regimens on C-reactive protein? 7. What are the effects of the tested regimens on Hematological indices? 8. What are the effects of the tested regimens on Rate pressure product? Participants will be separated into four groups: 1. Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days 2. Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days. 3. Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once daily for 60 days. 4. Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days. Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on IL-1, IL-6 ,Fasting Blood Glucose, HbA1c, Body Mass Index, Lipid profile, Rate pressure product, C-reactive protein, and Hematological indices. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
Placebo Capsule / Capsules per oral / once daily / 60 days duration
Al-Zahraa Teaching Hospital
Wāsiţ, Iraq
Serum interleukin-1 (IL-1) Level
Measured in Pg/mL
Time frame: At Baseline, and After 60 days of treatment.
Serum interleukin-15 (IL-15) Level
Measured in Pg/mL
Time frame: At Baseline, and After 60 days of treatment.
Fasting Blood Sugar (FBS)
Measured in mg/dL
Time frame: At Baseline, and After 60 days of treatment.
Hemoglobin A1C (HbA1C)
Measured in percent from total Hemoglobin
Time frame: At Baseline, and After 60 days of treatment.
Body Mass Index (BMI)
Measured in Kg/m²
Time frame: At baseline, and after 60 days of treatment
Serum C-reactive protein (CRP)
Measured in mg/dL
Time frame: At baseline, and after 60 days of treatment
Rate Pressure Product
Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)
Time frame: At baseline, and after 60 days of treatment.
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