Probiotics and Gut Health

NCT03418857 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-14

No results posted yet for this study

Summary

This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

Yogurt smoothie with BB-12

During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.

DRUG

Yogurt smoothie

During the one month control period, the participants will consume one yogurt smoothie daily.

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED
  • Penn State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2022-10-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03418857 on ClinicalTrials.gov