Clinical trial NCT06007430: Colostrum Supplements Effect on the Physical Performance and Cognitive Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Colostrum
Diabetes Mellitus, Type 2
Cognition
Physical Functional Performance
Lead sponsor: Al-Mustafa University College
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 for 60 days.
3. Group 3 (Diabetes Type 2): 23 Patieints, 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum interleukin-1 (IL-1) Level
timeFrame: At Baseline, and After 60 days of treatment.
measure: Serum interleukin-15 (IL-15) Level
timeFrame: At Baseline, and After 60 days of treatment.
measure: Fasting Blood Sugar (FBS)
timeFrame: At Baseline, and After 60 days of treatment.
measure: Hemoglobin A1C (HbA1C)
timeFrame: At Baseline, and After 60 days of treatment.
measure: Body Mass Index (BMI)
timeFrame: At baseline, and after 60 days of treatment
Secondary outcomes:
measure: Serum C-reactive protein (CRP)
timeFrame: At baseline, and after 60 days of treatment
measure: Rate Pressure Product
timeFrame: At baseline, and after 60 days of treatment.
Other outcomes:
Locations:
city: Wasit
country: Iraq
facility: Al-Zahraa Teaching Hospital
Study officials:
affiliation: Al-Farabi Kazakh National University
name: Ahmed Khalid Mohammed Albasri, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Mustafa University College
name: Hayder Adnan Fawzi, PhD
role: STUDY_CHAIR
References: