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

NCT06549556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-13

No results posted yet for this study

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.
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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

  • Al-Farabi Kazakh National University

    collaborator UNKNOWN

  • Al-Rasheed University College

    lead OTHER

Principal Investigators

  • Ahmed Khalid Mohammed Albasri, MSc. Pharmacology · Al-Farabi Kazakh National University

  • Hayder Adnan Fawzi, PhD. Clinical Pharmacy · Al-Rasheed University College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2024-12-10
Completion
2024-12-10

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549556 on ClinicalTrials.gov