The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes
NCT ID: NCT06549556
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2024-08-20
2024-12-10
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1 (Healthy Control)
24 Patients receiving Placebo Capsule per oral once daily for 60 days.
Placebo
Placebo Capsule / Capsules per oral / once daily / 60 days duration
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.
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.
Group 3 (Diabetes Type 2)
23 Patients receiving Placebo Capsule per oral once daily for 60 days.
Placebo
Placebo Capsule / Capsules per oral / once daily / 60 days duration
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.
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.
Interventions
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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
Placebo Capsule / Capsules per oral / once daily / 60 days duration
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with T2DM
* Age between 18-70
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Al-Farabi Kazakh National University
UNKNOWN
Al-Rasheed University College
OTHER
Responsible Party
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Hayder Adnan Fawzi
Assistant Prof
Principal Investigators
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Ahmed Khalid Mohammed Albasri, MSc. Pharmacology
Role: PRINCIPAL_INVESTIGATOR
Al-Farabi Kazakh National University
Hayder Adnan Fawzi, PhD. Clinical Pharmacy
Role: STUDY_CHAIR
Al-Rasheed University College
Locations
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Al-Zahraa Teaching Hospital
Wāsiţ, , Iraq
Countries
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Other Identifiers
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4-3672 in 27/10/2024
Identifier Type: -
Identifier Source: org_study_id