NCT06549556

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Al-Rasheed University College · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2024-08-12
• Last updated: 2024-12-13

Locations

1 site across 1 country: Iraq