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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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
Yes
Al-Zahraa Teaching Hospital
Wāsiţ, Iraq
Start Date
August 20, 2024
Primary Completion Date
December 10, 2024
Completion Date
December 10, 2024
Last Updated
December 13, 2024
100
ACTUAL participants
Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
DRUG
Placebo
OTHER
Lead Sponsor
Al-Rasheed University College
Collaborators
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06861062