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A Study Investigating the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population

NCT04147923 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-05-08

No results posted yet for this study

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

  • Healthy

Interventions

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

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Kaneka Americas Holding Inc.

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2023-06-02
Completion
2023-06-02

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147923 on ClinicalTrials.gov