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NCT Number: NCT06549556

The Value of Using Colostrum Supplements on the Physical Performance and Cognitive Function in Healthy Subjects and Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-Zahraa Teaching Hospital

Wāsiţ, 52001, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Other

Placebo Capsule / Capsules per oral / once daily / 60 days duration

Primary outcomes

  1. Serum IL-1 Level

    Time frame: at Baseline, and After 60 days of treatment.

    Measured in Pg/mL

  2. Serum IL-15 Level

    Time frame: at Baseline, and After 60 days of treatment.

    Measured in Pg/mL

  3. Fasting Blood Sugar (FBS)

    Time frame: at Baseline, and After 60 days of treatment.

    Measured in mg/dL

  4. Hemoglobin A1C (HbA1C)

    Time frame: at Baseline, and After 60 days of treatment.

    Measured in percent from total Hemoglobin

  5. Body Mass Index (BMI)

    Time frame: at baseline, and after 60 days of treatment.

    Measured in Kg/m²

Secondary outcomes

  1. Serum C-reactive protein (CRP)

    Time frame: At baseline, and after 60 days of treatment

    Measured in mg/dL

  2. Rate Pressure Product

    Time frame: at Baseline, and after 60 days of treatment.

    Measured in an equation combining Heart rate in (BPM) and blood pressure in (mmHg)

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Collaborators

  • Al-Farabi Kazakh National University

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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