---
title: Probiotics and Gut Health
nct_id: NCT03418857
overall_status: RECRUITING
phase: PHASE1, PHASE2
sponsor: Penn State University
study_type: INTERVENTIONAL
primary_condition: Metabolic Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03418857.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03418857"
ct_last_update_post_date: 2021-12-14
last_seen_at: "2026-05-12T07:14:55.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Probiotics and Gut Health

**Official Title:** The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults

**NCT ID:** [NCT03418857](https://clinicaltrials.gov/study/NCT03418857)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Penn State University
- **Collaborators:** United States Department of Agriculture (USDA)
- **Conditions:** Metabolic Syndrome
- **Start Date:** 2018-06-29
- **Completion Date:** 2022-12
- **CT.gov Last Update:** 2021-12-14

## Brief 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.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* BMI ≥ to 25 and less than 35 kg/m\^2
* Increased waist circumference (men: ≥ 94 cm, women: ≥ 80 cm)
* At least one of the metabolic syndrome criteria-
* serum triglycerides: ≥ 150 mg/dL
* HDL cholesterol: ≤ 40 mg/dL in men, ≤ 50 mg/dL in women
* blood pressure: ≥ 130 mmHg systolic or ≥ 85 mmHg diastolic
* fasting plasma glucose ≥ 100 mg/dL

Exclusion Criteria:

* allergy to dairy
* smoking and/or use of tobacco products
* systolic blood pressure ≥ 160 mmHg
* diastolic blood pressure \> 100 mmHg
* fasting glucose ≥ 126 mg/dL
* history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
* use of cholesterol or lipid lowering medications
* use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
* refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
* clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
* Use of antibiotics within the last 2 months
* excessive alcohol consumption (≥ 14 standard drinks per week)
* regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)
```

## 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.
- **Control** (PLACEBO_COMPARATOR) — 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.

## 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.

## Primary Outcomes

- **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))_ — Change in inflammatory markers in the serum and secreted cytokines from lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells compared to baseline. In the serum the markers to be investigated are high sensitivity c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-a), interleukin 1 beta (IL-1B), IL-6, IL-8, IL-10, IL-12p70, monocyte chemotactic protein 1 (MCP-1), macrophage inflammatory protein alpha (MIP-1a), sCD14, and LPS binding protein (LPB). From LPS-stimulated peripheral blood mononuclear cells the cytokines to be investigated are TNF-a, IL-1B, IL-6, IL-8, IL-10, IL-12p70, MCP-1, and MIP-1a. Changes in these inflammatory markers will assist in understanding how the consumption of yogurt containing BB-12 affects the inflammatory status of obese individuals.

## Secondary Outcomes

- **Change in number and activation of leukocytes** _(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))_
- **Change in gut permeability** _(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))_
- **Change in gut microbiota populations** _(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))_
- **Change in metabolism of gut microbiota populations** _(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))_

## Locations (1)

- The Pennsylvania State University, University Park, Pennsylvania, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the pennsylvania state university|university park|pennsylvania|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03418857.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03418857*  
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