Actively Recruiting

Phase 1
Phase 2
Age: 55Years - 75Years
All Genders
NCT03418857

Probiotics and Gut Health

Led by Penn State University · Updated on 2021-12-14

40

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

P

Penn State University

Lead Sponsor

U

United States Department of Agriculture (USDA)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Probiotics and Gut Health

Who Can Participate

Age: 55Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI of 25 or higher and less than 35 kg/m2
  • Increased waist circumference (men: at least 94 cm, women: at least 80 cm)
  • At least one metabolic syndrome criterion: triglycerides 150 mg/dL or higher, HDL cholesterol 40 mg/dL or less in men or 50 mg/dL or less in women, blood pressure 130 mmHg systolic or 85 mmHg diastolic or higher, or fasting plasma glucose 100 mg/dL or higher
Not Eligible

You will not qualify if you...

  • Allergy to dairy products
  • Current smoking or use of tobacco products
  • Systolic blood pressure 160 mmHg or higher
  • Diastolic blood pressure over 100 mmHg
  • Fasting glucose 126 mg/dL or higher
  • History of heart attack, cardiovascular disease, stroke, diabetes, liver, kidney, or thyroid disease unless controlled with medication
  • Use of cholesterol or lipid-lowering medications
  • Use of anti-hypertensive or glucose-lowering supplements including psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, or stanol/sterol foods
  • Refusal to stop nutritional supplements, herbs, vitamins, or probiotics
  • Diagnosis of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  • Use of antibiotics in the last 2 months
  • Excessive alcohol intake (14 or more standard drinks per week)
  • Regular use of anti-inflammatory medications like aspirin or ibuprofen

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Pennsylvania State University

University Park, Pennsylvania, United States, 16802

Actively Recruiting

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Research Team

C

Connie J Rogers, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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