Recruiting
Phase 1
Phase 2

Probiotics

Sponsor:

Penn State University

Code:

NCT03418857

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Yogurt smoothie with BB-12

Yogurt smoothie

Study Details

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.

Conditions

Metabolic Syndrome

Study ID

NCT03418857

Start date

Jun 29, 2018

Status verified date

Dec, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

placebo comparator: Control

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

During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.

Yogurt smoothie

During the one month control period, the participants will consume one yogurt smoothie daily.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Connie J Rogers, PhD, MPH

814 867 3716cjr102@psu.edu

Locations

The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Connie J Rogers

cjr102@psu.edu

Principal Investigator:

Connie J Rogers, PhD, MPH

More Information

Sponsor

Penn State University

Last update posted

Dec 14, 2021

Last verified

Dec, 2021

Keywords

  • probiotics
  • Human
  • obesity
  • non-pharmacologic therapy
  • gut health
  • microbiome
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2021-12-14.