Colostrum Supplements Effect on the Physical Performance and Cognitive Function

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Placebo; Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)

• Registration Number: NCT06007430
• Lead Sponsor: Al-Mustafa University College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-10-15
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 (Diabetes Type 2)	Placebo	23 Patients receiving Placebo Capsule per oral once daily for 60 days.
Group 1 (Healthy Control)	Placebo	24 Patients receiving Placebo Capsule per oral once daily for 60 days.
Group 2 (Healthy control)	Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)	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 4 (Diabetes Type 2)	Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)	27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.

Primary Outcome Measures

Name	Time	Method
Serum interleukin-1 (IL-1) Level	At Baseline, and After 60 days of treatment.	Measured in Pg/mL
Serum interleukin-15 (IL-15) Level	At Baseline, and After 60 days of treatment.	Measured in Pg/mL
Fasting Blood Sugar (FBS)	At Baseline, and After 60 days of treatment.	Measured in mg/dL
Hemoglobin A1C (HbA1C)	At Baseline, and After 60 days of treatment.	Measured in percent from total Hemoglobin
Body Mass Index (BMI)	At baseline, and after 60 days of treatment	Measured in Kg/m²

Secondary Outcome Measures

Name	Time	Method
Serum C-reactive protein (CRP)	At baseline, and after 60 days of treatment	Measured in mg/dL
Rate Pressure Product	At baseline, and after 60 days of treatment.	Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)

Trial Locations

Locations (1)

Al-Zahraa Teaching Hospital; 🇮🇶 Wasit, Iraq