NCT06549556CompletedPhase 2
The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 13 Dec 2024
Brief summary (registry, in English)
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. 3. Group 3 (Diabetes Type 2): 23 Pateins, 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. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 20 Aug 2024
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Al-Rasheed University College
- Diseases
- Type 2 diabetes
- NCT number
- NCT06549556
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 20 Aug 2024 to the primary completion date, 10 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Patients with T1DM
- Pregnancy, lactation, or female patient willing for conception.
Who the study is looking for
- Apperantly Healthy patients for control
- Patients diagnosed with T2DM
- Age between 18-70
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Zahraa Teaching Hospital Coordinator of this site? Confirm its status | Wāsiţ | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.