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-Rasheed University College
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Serum 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.
- Group 3 (Diabetes Type 2): 23 Pateins, 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.
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.
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
- •Apperantly 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 IL-1 Level
Time Frame: at Baseline, and After 60 days of treatment.
Measured in Pg/mL
Serum IL-15 Level
Time Frame: at Baseline, and After 60 days of treatment.
Measured in Pg/mL
Hemoglobin A1C (HbA1C)
Time Frame: at Baseline, and After 60 days of treatment.
Measured in percent from total Hemoglobin
Fasting Blood Sugar (FBS)
Time Frame: at Baseline, and After 60 days of treatment.
Measured in mg/dL
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-Rasheed University College