Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2018-06-29
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
Yogurt smoothie with BB-12
During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
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.
Yogurt smoothie
During the one month control period, the participants will consume one yogurt smoothie daily.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
75 Years
ALL
No
Sponsors
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United States Department of Agriculture (USDA)
FED
Penn State University
OTHER
Responsible Party
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Connie J Rogers
Associate Professor of Nutritional Sciences
Locations
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The Pennsylvania State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Connie J Rogers
Role: primary
References
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Meng H, Ba Z, Lee Y, Peng J, Lin J, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 in yogurt reduced expression of TLR-2 on peripheral blood-derived monocytes and pro-inflammatory cytokine secretion in young adults. Eur J Nutr. 2017 Mar;56(2):649-661. doi: 10.1007/s00394-015-1109-5. Epub 2015 Nov 30.
Aggarwal BB. Targeting inflammation-induced obesity and metabolic diseases by curcumin and other nutraceuticals. Annu Rev Nutr. 2010 Aug 21;30:173-99. doi: 10.1146/annurev.nutr.012809.104755.
Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8.
Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.
Sugahara H, Odamaki T, Fukuda S, Kato T, Xiao JZ, Abe F, Kikuchi J, Ohno H. Probiotic Bifidobacterium longum alters gut luminal metabolism through modification of the gut microbial community. Sci Rep. 2015 Aug 28;5:13548. doi: 10.1038/srep13548.
Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M. Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12(R) and Lactobacillus paracasei ssp. paracasei, L. casei 431(R) in an influenza vaccination model: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2012 Mar;107(6):876-84. doi: 10.1017/S000711451100420X. Epub 2011 Sep 7.
Other Identifiers
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STUDY0006843
Identifier Type: -
Identifier Source: org_study_id