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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230928002
Enrollment
80
Registered
2023-09-28
Start date
2023-11-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy elderly, aged 55-70 years. Colostrum

Interventions

Colosure (50 g), dissolved with 180 mL of water, taken orally, twice daily, for 12 weeks,Placebo (50 g), dissolved with 180 mL of water, taken orally, twice daily, for 12 weeks
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Colosure dietary supplement product,Placebo

Sponsors

Program Management Unit for Competitiveness (PMUC)
Lead Sponsor
Wellnovations Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All
Age
55 Years to 70 Years

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Upper 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

Countries

Thailand

Contacts

Public ContactNut Koonrungsesomboon

Chiang Mai University

nut.koonrung@cmu.ac.th053935353

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026