51¸£Àû

Description of Study

Participate in this study to help us learn about how Weizmannia (Bacillus) Coagulans, a probiotic, can impact your gut health. A probiotic is a live microorganism that, when consumed in adequate amounts, provides health benefits by promoting the growth of beneficial bacteria in the gut.

• Download Overview

Location
(Fieldhouse 126)
209 S Kingshighway St
Saint Charles, MO 63301

Number of Visits
5 visits over 12 weeks

Time Commitment
Visit 1 (Virtual): 30 minutes
Visits 2-5 (in-person): 45 minutes each

Compensation
$250

Points of Contact
EPNL
[email protected]

Research Sample Needed

• 30 healthy, physically active males and females who occasionally experience mild to severe bloating

Inclusion Criteria

• Ages of 18 – 50 years
• Average daily bloating score >5 on question 3 of the Modified daily Abdominal, Gas, and Bloating Questionnaire and/or bloating for >5 days during the past 14 days
• Body mass index (BMI) 18.5 – 29.9 kg/m2 (Inclusive) (Individuals >29.9 kg/m2, but <25% fat for men and <30% fat for women will be accepted into the study. The cohort average of body mass index will not exceed 29.9 kg/m2)
• Weight stable for the past three months (defined as less than a 5% variation in body mass over this time)
• Determined to be healthy through completion of a health history questionnaire
• Subject agrees to maintain their existing dietary patterns throughout the study period and to report to study investigators any changes particularly as they relate to probiotic-containing or fermented foods
• Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours prior to each test day.
• Minimum baseline physical activity level (defined as at least 30 minutes of moderate intensity exercise at least 4 days per week for the past 3 months)
• Subject is willing and able to comply with the study protocol.
• Study participant is not currently enrolled in another clinical trial that involves the administration of some investigative agent

Exclusion Criteria

• Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
• Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
• Has liver disease or some form of clinically diagnosed hepatic impairment
• Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
• Diagnosed with or is being treated for some form of thyroid disease
• Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
• Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
• History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
• Participant has been treated for a gastrointestinal related disorder, complication, or disorder within the past 30 days
• Positive medical history for any neurological condition or neurological disease
• Diagnosed with or being treated for any endocrinological disorder or currently used any form of hormone replacement (prescribed/doctor ordered or not)
• Women with a history of hormone-related conditions such as endometriosis, fibroids, polycystic ovary syndrome
• Currently prescribed for the first time statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months
• Currently prescribed for the first time hypertension medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months
• Current antibiotic use or other prescription or over-the-counter medications that may impact study outcomes
• Have a known sensitivity or allergy to any of the study products
• Blood donation in past 60 days
• Current smoker (average of > 1 pack per week within the past 3 months) or has quit within the past six months. This includes all forms of nicotine
• They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study
• Competitive athletes will be excluded
• History of alcohol or substance abuse in the 12 months prior to screening
• Current use of anabolic steroids (medically prescribed or otherwise)
• Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol
• Report taking a probiotic or other dietary supplement know to impact digestion or gut function in the past 30 days
• Recent history (<3 months) of exercise training or weight loss (> 5%)
• Currently following a ketogenic or low carbohydrate diet within the past 30 days.
• Women who are pregnant, planning to become pregnant, or lactating currently or within the past six months
•  

Are You Eligible?

• .

Information provided here reflects current IRB approval for this research. However, this information may be subject to change and updated accordingly.