The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes

Sponsor

Al-Mustafa University College (Other)

Overall Status

Recruiting

CT.gov ID

NCT06007430

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1 (Healthy Control) 24 Patients receiving Placebo Capsule per oral once daily for 60 days.	Other: Placebo Placebo Capsule / Capsules per oral / once daily / 60 days duration
Active Comparator: Group 2 (Healthy control) 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) Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
Placebo Comparator: Group 3 (Diabetes Type 2) 23 Patients receiving Placebo Capsule per oral once daily for 60 days.	Other: Placebo Placebo Capsule / Capsules per oral / once daily / 60 days duration
Active Comparator: Group 4 (Diabetes Type 2) 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) Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Zahraa Teaching Hospital	Wasit		Iraq	52001

Sponsors and Collaborators

Al-Mustafa University College

Investigators

Principal Investigator: Ahmed Khalid Mohammed Albasri, MSc. Pharmacology, Al-Farabi Kazakh National University
Study Chair: Hayder Adnan Fawzi, PhD. Clinical Pharmacy, Al-Mustafa University College