Trials / Completed
CompletedNCT04147923
A Study Investigating the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Kaneka Americas Holding Inc. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
This trial will be investigating the effect for Floradapt Mature Immune Defense on nutrient uptake and digestive health in a healthy elderly population. Approximately 120 healthy older adults will be enrolled into the study and will consume either the probiotic or placebo supplement for 84 days and complete questionnaires as well as provide blood samples for nutrient uptake analysis (for 50 participants), immunological markers, and general markers of health. Saliva samples will be provided for analysis of sIgA and cortisol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Floradapt Mature Immune Defense + Multivitamin | The product consists of two L. plantarum strains, KABP XXXX and KABP XXXX with a combined strength of \>1 x 10\^9 CFU. Participants will also consume a multivitamin. |
| DIETARY_SUPPLEMENT | Placebo + Multivitamin | No active ingredients + a multivitamin supplement |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2023-06-02
- Completion
- 2023-06-02
- First posted
- 2019-11-01
- Last updated
- 2024-05-08
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04147923. Inclusion in this directory is not an endorsement.