Overview
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:
- What are the effects of the tested regimens on the level of IL-1 and IL-15.
- What are the effects of the tested regimens on the Fasting Blood glucose?
- What are the effects of the tested regimens on the HbA1C?
- What are the effects of the tested regimens on the Body Mass Index?
- What are the effects of the tested regimens on the Lipid profile?
- What are the effects of the tested regimens on C-reactive protein?
- What are the effects of the tested regimens on Hematological indices?
- What are the effects of the tested regimens on Rate pressure product?
Participants will be separated into four groups:
- Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
- Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days.
- Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once daily for 60 days.
- 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.
Eligibility
Inclusion Criteria:
- Apparently Healthy patients for control
- Patients diagnosed with T2DM
- Age between 18-70
Exclusion Criteria:
- Patients with T1DM
- Patients with a drug history of anabolic substances for more than 14 days duration.
- Patients with co-morbidities (e.g. CVS, renal, hepatic, and endocrine disorders)
- Pregnancy, lactation, or female patient willing for conception.