Academics

Effect of a Probiotic on Gut Health and Fecal Microbiome Changes

Effect of a Probiotic on Gut Health and Fecal Microbiome Changes

Academics NAVIGATION

Effect of a Probiotic on Gut Health and Fecal Microbiome Changes

LU IRB#: IRB-25-41
PI: Chad Kerksick, PhD

Description of Study

Participate in this study to help us learn about how Geranylceraniol (GG) can impact your body composition and exercise performance. GG is a compound found in many foods that may help improve body composition, muscle strength and exercise performance.

Flowchart Image

Location
Exercise and Performance Nutrition Laboratory (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
epnl@lindenwood.edu

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.