Colostrum Supplements Effect on the Physical Performance and Cognitive Function

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007430
• Other study ID #: 4-3672 in 27/10/2024
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2023
• Source: Al-Mustafa University College
• Contact: Ahmed Khalid Mohammed Albasri, MSc
• Phone: +9647812831612
• Email: ahmedalbasri28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.

Other:
• Placebo
Placebo Capsule / Capsules per oral / once daily / 60 days duration

Locations

Country	Name	City	State
Iraq	Al-Zahraa Teaching Hospital	Wasit

Sponsors (1)

Lead Sponsor	Collaborator
Al-Mustafa University College

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum interleukin-1 (IL-1) Level	Measured in Pg/mL	At Baseline, and After 60 days of treatment.
Primary	Serum interleukin-15 (IL-15) Level	Measured in Pg/mL	At Baseline, and After 60 days of treatment.
Primary	Fasting Blood Sugar (FBS)	Measured in mg/dL	At Baseline, and After 60 days of treatment.
Primary	Hemoglobin A1C (HbA1C)	Measured in percent from total Hemoglobin	At Baseline, and After 60 days of treatment.
Primary	Body Mass Index (BMI)	Measured in Kg/m²	At baseline, and after 60 days of treatment
Secondary	Serum C-reactive protein (CRP)	Measured in mg/dL	At baseline, and after 60 days of treatment
Secondary	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.