Colostrum Supplements Effect on the Physical Performance and Cognitive Function

Study Overview
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Brief Summary
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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: 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.

Official Title
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The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes: A Case-management Comparative Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1 (Healthy Control)<br>24 Patients receiving Placebo Capsule per oral once daily for 60 days. | Other: Placebo<br>* Placebo Capsule / Capsules per oral / once daily / 60 days duration<br>|
| Active Comparator: Group 2 (Healthy control)<br>26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. | Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)<br>* Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.<br>* Other names: Colostrum®;|
| Placebo Comparator: Group 3 (Diabetes Type 2)<br>23 Patients receiving Placebo Capsule per oral once daily for 60 days. | Other: Placebo<br>* Placebo Capsule / Capsules per oral / once daily / 60 days duration<br>|
| Active Comparator: Group 4 (Diabetes Type 2)<br>27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. | Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)<br>* Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.<br>* Other names: Colostrum®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | At baseline, and after 60 days of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance