Clinical trial

Probiotics and Gut Health

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT03418857

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionMetabolic Syndrome

Full registry criteria

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)

Treatments and study arms

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 markersAt 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Pennsylvania State University🇺🇸 University Park, Pennsylvania, United States
Connie J RogersContact
Connie J Rogers, PhD, MPHPrincipal Investigator