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

NCT06549556 | Completed Phase 2 DMC

• 1 other identifier: 4-3672 in 27/10/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.What are the effects of the tested regimens on the level of IL-1 and IL-15.
2. 2.What are the effects of the tested regimens on the Fasting Blood glucose?
3. 3.What are the effects of the tested regimens on the HbA1C?
4. 4.What are the effects of the tested regimens on the Body Mass Index?
5. 5.What are the effects of the tested regimens on the Lipid profile?
6. 6.What are the effects of the tested regimens on C-reactive protein?
7. 7.What are the effects of the tested regimens on Hematological indices?
8. 8.What are the effects of the tested regimens on Rate pressure product?
9. 9.Group 1 (Healthy control): 24 Patients, will be receiving Placebo Capsule per oral once daily for 60 days
10. 10.Group 2 (Healthy control) : 26 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.
11. 11.Group 3 (Diabetes Type 2): 23 Pateins, will be receiving Placebo Capsule per oral once daily for 60 days
12. 12.Group 4 (Diabetes Type 2) : 27 Patients, will be receiving Colostrum Capsule 500 mg per oral once daily.

Conditions

Diabetes Mellitus, Type 2

Keywords

Colostrum; Diabetes Mellitus, Type 2; Cognition; Physical Functional Performance

Outcome Measures

Primary Outcomes (5)

• Serum IL-1 Level

  Measured in Pg/mL

  at Baseline, and After 60 days of treatment.

• Serum IL-15 Level

  Measured in Pg/mL

  at Baseline, and After 60 days of treatment.

• Fasting Blood Sugar (FBS)

  Measured in mg/dL

  at Baseline, and After 60 days of treatment.

• Hemoglobin A1C (HbA1C)

  Measured in percent from total Hemoglobin

  at Baseline, and After 60 days of treatment.

• Body Mass Index (BMI)

  Measured in Kg/m²

  at baseline, and after 60 days of treatment.

Secondary Outcomes (2)

• Serum C-reactive protein (CRP)

  At baseline, and after 60 days of treatment

• Rate Pressure Product

  at Baseline, and after 60 days of treatment.

Study Arms (4)

Group 1 (Healthy Control)

PLACEBO COMPARATOR

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

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.

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.

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.

Drug: Colostrum Capsule 500 mg (Colostrum® 500 mg Veg Capsules, nowfoods®, Illinois, USA)

Interventions

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.

Group 2 (Healthy control); Group 4 (Diabetes Type 2)

Placebo OTHER

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

Group 1 (Healthy Control); Group 3 (Diabetes Type 2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apperantly Healthy patients for control
• Patients diagnosed with T2DM
• Age between 18-70

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Rasheed University College: lead
• Al-Farabi Kazakh National University: collaborator

Study Sites (1)

Al-Zahraa Teaching Hospital

Wāsiţ, 52001, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ahmed Khalid Mohammed Albasri, MSc. Pharmacology

  Al-Farabi Kazakh National University

  PRINCIPAL INVESTIGATOR

• Hayder Adnan Fawzi, PhD. Clinical Pharmacy

  Al-Rasheed University College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 20, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

IR (1)