Diabetes Mellitus, Type 2Phase 2NCT06549556
The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes
A Phase 2 study testing Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) in people with Diabetes Mellitus, Type 2, run by Al-Rasheed University College at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 20 Aug 2024to 10 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apperantly Healthy patients for control
- Patients diagnosed with T2DM
- Age between 18-70
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), Placebo
- Keywords
- Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)Drug
Brand name: (Colostrum® 500 mg Veg Capsules) capsules per oral / once daily / 60 days duration.
PlaceboOther
Placebo Capsule / Capsules per oral / once daily / 60 days duration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Healthy Control) | Placebo comparator | 24 Patients receiving Placebo Capsule per oral once daily for 60 days. Receives: Other: Placebo |
| Group 2 (Healthy control) | Active comparator | 26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. Receives: Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) |
| Group 3 (Diabetes Type 2) | Placebo comparator | 23 Patients receiving Placebo Capsule per oral once daily for 60 days. Receives: Other: Placebo |
| Group 4 (Diabetes Type 2) | Active comparator | 27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. Receives: Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IL-1 Level
Measured in Pg/mL
Measured: at Baseline, and After 60 days of treatment.
Serum IL-15 Level
Measured in Pg/mL
Measured: at Baseline, and After 60 days of treatment.
Fasting Blood Sugar (FBS)
Measured in mg/dL
Measured: at Baseline, and After 60 days of treatment.
Hemoglobin A1C (HbA1C)
Measured in percent from total Hemoglobin
Measured: at Baseline, and After 60 days of treatment.
Body Mass Index (BMI)
Measured in Kg/m²
Measured: at baseline, and after 60 days of treatment.
Secondary outcomes (2)
Serum C-reactive protein (CRP)
Measured in mg/dL
Measured: At baseline, and after 60 days of treatment
Rate Pressure Product
Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)
Measured: at Baseline, and after 60 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start20 Aug 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Farabi Kazakh National University
- Responsible party
- Principal investigator, Hayder Adnan Fawzi, Al-Rasheed University College
- Investigators
- Ahmed Khalid Mohammed Albasri, MSc. Pharmacology, Principal investigator, Al-Farabi Kazakh National UniversityHayder Adnan Fawzi, PhD. Clinical Pharmacy, Study chair, Al-Rasheed University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549556
- Sponsor's protocol ID
- 4-3672 in 27/10/2024
- Status last verified
- Dec 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06549556
- Acronym / sponsor ID
- 4-3672 in 27/10/2024
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Colostrum, Diabetes Mellitus, Type 2, Cognition, Physical Functional Performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Collaborators
- Al-Farabi Kazakh National University
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Healthy Control) | Placebo comparator | Other: Placebo24 Patients receiving Placebo Capsule per oral once daily for 60 days. |
| Group 2 (Healthy control) | Active comparator | Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)26 Patients receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. |
| Group 3 (Diabetes Type 2) | Placebo comparator | Other: Placebo23 Patients receiving Placebo Capsule per oral once daily for 60 days. |
| Group 4 (Diabetes Type 2) | Active comparator | Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)27 Patients Receiving Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA), one capsule per oral once daily for 60 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Apperantly Healthy patients for control
- Patients diagnosed with T2DM
- Age between 18-70
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group 2 (Healthy control), Group 4 (Diabetes Type 2) |
| PlaceboPlacebo Capsule / Capsules per oral / once daily / 60 days duration | Other | Group 1 (Healthy Control), Group 3 (Diabetes Type 2) |
Primary outcome
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
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
2 secondary outcomes
Serum C-reactive protein (CRP)
Time frame: At baseline, and after 60 days of treatment
Rate Pressure Product
Time frame: at Baseline, and after 60 days of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Khalid Mohammed Albasri, MSc. Pharmacology principal investigator
Al-Farabi Kazakh National University
Hayder Adnan Fawzi, PhD. Clinical Pharmacy study chair
Al-Rasheed University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA) in people with Diabetes Mellitus, Type 2, run by Al-Rasheed University College at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IL-1 Level (time frame: at Baseline, and After 60 days of treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.