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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:
Participants will be separated into four groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Healthy Control) | Placebo Comparator | 24 Patients receiving Placebo Capsule per oral once daily for 60 days. |
|
| Group 2 (Healthy control) | Active Comparator | 26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. |
|
| Group 3 (Diabetes Type 2) | Placebo Comparator | 23 Patients receiving Placebo Capsule per oral once daily for 60 days. |
|
| Group 4 (Diabetes Type 2) | Active Comparator | 27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) | Drug | Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum interleukin-1 (IL-1) Level | Measured in Pg/mL | At Baseline, and After 60 days of treatment. |
| Serum interleukin-15 (IL-15) Level | Measured in Pg/mL | At Baseline, and After 60 days of treatment. |
| Fasting Blood Sugar (FBS) | Measured in mg/dL | At Baseline, and After 60 days of treatment. |
| Hemoglobin A1C (HbA1C) | Measured in percent from total Hemoglobin | At Baseline, and After 60 days of treatment. |
| Body Mass Index (BMI) | Measured in Kg/m² | At baseline, and after 60 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum C-reactive protein (CRP) | Measured in mg/dL | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Khalid Mohammed Albasri, MSc | Al-Farabi Kazakh National University | Principal Investigator |
| Hayder Adnan Fawzi, PhD | Al-Mustafa University College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Zahraa Teaching Hospital | Wāsiţ | 52001 | Iraq |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Placebo | Other | Placebo Capsule / Capsules per oral / once daily / 60 days duration |
|
| At baseline, and after 60 days of treatment. |
| D004700 | Endocrine System Diseases |