Colostrum Supplements Effect on the Physical Performance and Cognitive Function

September 29, 2025 updated by: Hayder Adnan Fawzi, Al-Mustafa University College

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Other Names:
  • Colostrum®
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.
Other Names:
  • Colostrum®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum interleukin-1 (IL-1) Level
Time Frame: At Baseline, and After 60 days of treatment.
Measured in Pg/mL
At Baseline, and After 60 days of treatment.
Serum interleukin-15 (IL-15) Level
Time Frame: At Baseline, and After 60 days of treatment.
Measured in Pg/mL
At Baseline, and After 60 days of treatment.
Fasting Blood Sugar (FBS)
Time Frame: At Baseline, and After 60 days of treatment.
Measured in mg/dL
At Baseline, and After 60 days of treatment.
Hemoglobin A1C (HbA1C)
Time Frame: At Baseline, and After 60 days of treatment.
Measured in percent from total Hemoglobin
At Baseline, and After 60 days of treatment.
Body Mass Index (BMI)
Time Frame: At baseline, and after 60 days of treatment
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)
Time Frame: At baseline, and after 60 days of treatment
Measured in mg/dL
At baseline, and after 60 days of treatment
Rate Pressure Product
Time Frame: At baseline, and after 60 days of treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustafa University College

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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