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

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

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.
3. Group 3 (Diabetes Type 2): 23 Pateins, 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.

Researchers will compare Groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on Fasting Blood Glucose, HbA1c, Lipid profile, Rate pressure product, C-reactive protein, Hematological indices, and Body Mass Index. and use these measures In special formulas to determine the effect of the tested regimens on physical performance and cognitive function.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iraq
  • Wasit, Iraq, 52001
    • Al-Zahraa Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Apperantly 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IL-1 Level	Measured in Pg/mL	at Baseline, and After 60 days of treatment.
Serum 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.

Collaborators and Investigators

• Sponsor: Al-Rasheed University College
• Collaborators: Al-Farabi Kazakh National University
• Investigators: Principal Investigator: Ahmed Khalid Mohammed Albasri, MSc. Pharmacology, Al-Farabi Kazakh National University; Study Chair: Hayder Adnan Fawzi, PhD. Clinical Pharmacy, Al-Rasheed University College

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cognition; Diabetes Mellitus, Type 2; Colostrum; Physical Functional Performance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 4-3672 in 27/10/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No