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Colostrum Supplements Effect on the Physical Performance and Cognitive Function

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
Placebo
Sponsored by
Al-Mustafa University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Al-Zahraa Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Group 1 (Healthy Control)

Group 2 (Healthy control)

Group 3 (Diabetes Type 2)

Group 4 (Diabetes Type 2)

Arm Description

24 Patients receiving Placebo Capsule per oral once daily for 60 days.

26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.

23 Patients receiving Placebo Capsule per oral once daily for 60 days.

27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.

Outcomes

Primary Outcome Measures

Serum interleukin-1 (IL-1) Level
Measured in Pg/mL
Serum interleukin-15 (IL-15) Level
Measured in Pg/mL
Fasting Blood Sugar (FBS)
Measured in mg/dL
Hemoglobin A1C (HbA1C)
Measured in percent from total Hemoglobin
Body Mass Index (BMI)
Measured in Kg/m²

Secondary Outcome Measures

Serum C-reactive protein (CRP)
Measured in mg/dL
Rate Pressure Product
Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)

Full Information

First Posted
August 17, 2023
Last Updated
September 4, 2023
Sponsor
Al-Mustafa University College
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1. Study Identification

Unique Protocol Identification Number
NCT06007430
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Mustafa University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Healthy Control)
Arm Type
Placebo Comparator
Arm Description
24 Patients receiving Placebo Capsule per oral once daily for 60 days.
Arm Title
Group 2 (Healthy control)
Arm Type
Active Comparator
Arm Description
26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days.
Arm Title
Group 3 (Diabetes Type 2)
Arm Type
Placebo Comparator
Arm Description
23 Patients receiving Placebo Capsule per oral once daily for 60 days.
Arm Title
Group 4 (Diabetes Type 2)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
Other Intervention Name(s)
Colostrum®
Intervention Description
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsule / Capsules per oral / once daily / 60 days duration
Primary Outcome Measure Information:
Title
Serum interleukin-1 (IL-1) Level
Description
Measured in Pg/mL
Time Frame
At Baseline, and After 60 days of treatment.
Title
Serum interleukin-15 (IL-15) Level
Description
Measured in Pg/mL
Time Frame
At Baseline, and After 60 days of treatment.
Title
Fasting Blood Sugar (FBS)
Description
Measured in mg/dL
Time Frame
At Baseline, and After 60 days of treatment.
Title
Hemoglobin A1C (HbA1C)
Description
Measured in percent from total Hemoglobin
Time Frame
At Baseline, and After 60 days of treatment.
Title
Body Mass Index (BMI)
Description
Measured in Kg/m²
Time Frame
At baseline, and after 60 days of treatment
Secondary Outcome Measure Information:
Title
Serum C-reactive protein (CRP)
Description
Measured in mg/dL
Time Frame
At baseline, and after 60 days of treatment
Title
Rate Pressure Product
Description
Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)
Time Frame
At baseline, and after 60 days of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Khalid Mohammed Albasri, MSc
Phone
+9647812831612
Email
ahmedalbasri28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Khalid Mohammed Albasri, MSc
Organizational Affiliation
Al-Farabi Kazakh National University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hayder Adnan Fawzi, PhD
Organizational Affiliation
Al-Mustafa University College
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Zahraa Teaching Hospital
City
Wasit
ZIP/Postal Code
52001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayder Fadhil Lateef, PhD
Phone
+9647809412243
Email
Hf_nice@yahoo.com

12. IPD Sharing Statement

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Colostrum Supplements Effect on the Physical Performance and Cognitive Function

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