Probiotics and Gut Health (PRO)

The Pennsylvania State University (PENNSTATE)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Metabolic Syndrome

Treatments: Drug: Yogurt smoothie with BB-12; Drug: Yogurt smoothie

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03418857

STUDY0006843

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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.

Treatment:

Drug: Yogurt smoothie with BB-12

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Yogurt smoothie