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
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Al-Mustafa University College
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Serum interleukin-1 (IL-1) Level
Overview
Brief 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:
- What are the effects of the tested regimens on the level of IL-1 and IL-15.
- What are the effects of the tested regimens on the Fasting Blood glucose?
- What are the effects of the tested regimens on the HbA1C?
- What are the effects of the tested regimens on the Body Mass Index?
- What are the effects of the tested regimens on the Lipid profile?
- What are the effects of the tested regimens on C-reactive protein?
- What are the effects of the tested regimens on Hematological indices?
- What are the effects of the tested regimens on Rate pressure product?
Participants will be separated into four groups:
- Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
- Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily for 60 days.
- Group 3 (Diabetes Type 2): 23 Patieints, will be receiving Placebo Capsule per oral once daily for 60 days.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group 1 (Healthy Control)
24 Patients receiving Placebo Capsule per oral once daily for 60 days.
Intervention: Placebo (Other)
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.
Intervention: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) (Drug)
Group 3 (Diabetes Type 2)
23 Patients receiving Placebo Capsule per oral once daily for 60 days.
Intervention: Placebo (Other)
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.
Intervention: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) (Drug)
Outcomes
Primary Outcomes
Serum interleukin-1 (IL-1) Level
Time Frame: At Baseline, and After 60 days of treatment.
Measured in Pg/mL
Serum interleukin-15 (IL-15) Level
Time Frame: At Baseline, and After 60 days of treatment.
Measured in Pg/mL
Fasting Blood Sugar (FBS)
Time Frame: At Baseline, and After 60 days of treatment.
Measured in mg/dL
Hemoglobin A1C (HbA1C)
Time Frame: At Baseline, and After 60 days of treatment.
Measured in percent from total Hemoglobin
Body Mass Index (BMI)
Time Frame: At baseline, and after 60 days of treatment
Measured in Kg/m²
Secondary Outcomes
- Rate Pressure Product(At baseline, and after 60 days of treatment.)
- Serum C-reactive protein (CRP)(At baseline, and after 60 days of treatment)
Investigators
Hayder Adnan Fawzi
Assistant Prof.
Al-Mustafa University College