Taking people in United StatesPhase 1/2

Tests probiotic yogurt smoothies in older adults with metabolic syndrome

Compares yogurt smoothies with and without probiotics in adults with metabolic syndrome.

Key facts

Who runs it: Penn State University
Where: University Park, United StatesSee the site
Trial code: NCT03418857
Registry title: Probiotics and Gut Health
Status: Recruiting
Phase: Phase 1/2
People taking part: 40 people, planned
Started: 29 Jun 2018
Planned end: Dec 2022
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Yogurt smoothie with BB-12
Yogurt smoothie
Record updated: 14 December 2021

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 55 to 75 who are overweight or obese, have a larger waist and at least one sign of metabolic syndrome. They will eat yogurt with and without probiotics.

Age: 55 to 75 years
Sex: Men and women can join.
Disease stage: BMI of 25 or more and less than 35 kg/m^2. Waist of 94 cm (37 in) or more for men, 80 cm (31 in) or more for women. At least one metabolic syndrome sign, such as high triglycerides, low HDL cholesterol, raised blood pressure or raised fasting blood sugar.
Earlier treatment: No antibiotics in the last 2 months. No cholesterol or fat lowering medicines. No regular anti-inflammatory medicines such as aspirin or ibuprofen. Must be willing to stop supplements, herbs, vitamins and other probiotics.
Biomarker or test result: At least one of: triglycerides 150 mg/dL (1.7 mmol/L) or more; HDL cholesterol 40 mg/dL (1 mmol/L) or less in men, 50 mg/dL (1.3 mmol/L) or less in women; blood pressure 130 systolic or 85 diastolic or more; fasting blood glucose 100 mg/dL (5.6 mmol/L) or more.

Main reasons for not taking part

Allergy to dairy
Smoking or using tobacco products
Diabetes, heart disease, stroke, liver, kidney or thyroid disease (unless controlled with medicine)
Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
14 or more standard alcoholic drinks per week

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

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

Who cannot take part

use of cholesterol or lipid lowering medications
regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)
allergy to dairy
history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
fasting glucose ≥ 126 mg/dL
use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
smoking and/or use of tobacco products
systolic blood pressure ≥ 160 mmHg
diastolic blood pressure > 100 mmHg
refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
Use of antibiotics within the last 2 months
excessive alcohol consumption (≥ 14 standard drinks per week)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 55 and 75 years old?

Where in United States

The Pennsylvania State UniversityUniversity Park, United StatesContact: Connie J RogersTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

ExperimentalTreatment being tested
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: Yogurt smoothie with BB-12
ControlPlacebo, for comparison
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: Yogurt smoothie