Effects of the Colosure Dietary Supplement Product on Muscle, Bone, Immune, Cognitive Function Parameters in the Elderly: A Randomized, Double-Blind, Placebo-Controlled Trial

Phase 2

Recruiting

• Conditions: Healthy elderly, aged 55-70 years.; Colostrum; Immune; Bone; Muscle; Cognitive function; Elderly.

• Registration Number: TCTR20230928002
• Lead Sponsor: Program Management Unit for Competitiveness (PMUC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-28
• Study Completion: 2024-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age between 55-70 years
2. Weight of at least 40.0 kg and body mass index within the range of 18.5-22.9 kg/m2
3. General good health
4. Normal cognitive function or mild cognitive impairment
5. Able to provide written informed consent

Exclusion Criteria

1. Presence of any severe co-morbidity(ies), uncontrolled medical condition(s), or medical illness(es)
2. History of body metal implants or brachytherapy
3. History of hypersensitivity to any ingredients in the investigational product
4. Any other condition(s) in which any ingredients in the investigational product are contraindicated
5. Any other condition(s) that affects swallowing or consumption of the investigational product
6. Problem(s) with alcoholism, substance abuse, or heavy smoking
7. Use of a medication(s), herb(s), dietary supplement(s), or vitamin(s) that is likely to interact with any ingredients in the investigational product
8. Receives a vaccine(s) within 14 days (for inactivated vaccines) or 30 days (for live vaccines) or plan to receive any vaccines during the study period
9. Participates in another clinical trial concurrently or within 30 days
10. Plan to have a baby, or known or suspected pregnancy, or breastfeeding (for female patients)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune parameters 0, 4, 12 weeks Levels of immunoglobulins; Leukocyte counts and/or leukocyte subsets; and Levels of serum cytokines/inflammatory markers

Secondary Outcome Measures

Name	Time	Method
pper respiratory tract infection-related symptoms and other infections 0-12 weeks Upper respiratory tract infection-related symptoms and other infections,Body composition assessment 0, 12 weeks Muscle mass and bone mass,Bone markers 0, 12 weeks P1NP, osteocalcin or beta-CrossLaps,Cognitive function 0, 12 weeks TMSE and MoCA,Safety 0-12 weeks Safety assessment