Probiotics and Gut Health for Metabolic Syndrome

This study is looking at how a probiotic called BB-12 affects inflammation and gut health in people with metabolic syndrome. Metabolic syndrome is a group of conditions that increase your risk of heart disease, stroke, and type 2 diabetes. You would consume a yogurt smoothie with BB-12 for one month and a plain yogurt smoothie for another month, with a break in between. The order of these periods will be random. Researchers will measure changes in inflammatory markers to see if the probiotic has an effect. This study is for adults aged 55 to 75 who have a body mass index (BMI) between 25 and 35, increased waist circumference, and at least one other metabolic syndrome criterion like high triglycerides, low "good" cholesterol (HDL), high blood pressure, or high blood sugar. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design: This is an interventional study with 40 planned participants. You would receive both the yogurt smoothie with BB-12 and the plain yogurt smoothie at different times.
What's involved: You would consume one yogurt smoothie daily for two separate one-month periods, with a break in between. Inflammatory markers will be measured at four different times over 12 weeks.
Compensation: Not stated in the trial record.
Follow-up: The study measures outcomes up to 12 weeks after the start of the first intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Probiotics and Gut Health

Recruiting

PHASE1Ages 55–75InterventionalTreatment

Penn State University

~40 participants

Updated 2021-12-14 on ClinicalTrials.gov

What's tested:Yogurt smoothie with BB-12Yogurt smoothie

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from baseline in inflammatory markers

Measured over 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)

Conditions

Metabolic Syndrome

Where it's being run

1 sites across 1 states

Pennsylvania1

Who to contact

Connie J Rogers, PhD, MPH

[email protected]

814 867 3716

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

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.

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