Probiotics and Gut Health

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT03418857
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
55 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Yogurt smoothie with BB-12 — DRUG
    During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
  • Yogurt smoothie — DRUG
    During the one month control period, the participants will consume one yogurt smoothie daily.

Study Details

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.

Key Dates

Start date
Jun 29, 2018
Status verified
Dec 2021
Primary completion
Oct 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Participants will consume one yogurt smoothie daily for the duration of the intervention that contains 3.16 × 109 colony forming units (CFU) bifidobacterium animalis subsp. lactis BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.
  • Placebo Comparator: Control
    Participants will consume one yogurt smoothie daily for the duration of the intervention that contains no BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.

Primary Outcome Measure

Change from baseline in inflammatory markers [ Time Frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Pennsylvania State UniversityUniversity ParkPennsylvania16802
Connie J Rogers
[email protected]
Connie J Rogers, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
The Pennsylvania State University· University Park, PA

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