Status:
COMPLETED
Probiotic Administration on Mood
Lead Sponsor:
Lindenwood University
Collaborating Sponsors:
Increnovo, LLC
Conditions:
Depression
Sleep
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression, anxiety, stress, sleep quality, and associated emotional responses in healthy...
Detailed Description
In recent years, the presence and awareness of a connection between the intestines and the brain has expanded leading to the understanding of developed communication pathways between the nervous, endo...
Eligibility Criteria
Inclusion
- between the ages of 18 - 50 years
- has a body mass index between 18.5 - 30 kg/m2.
- Anyone with a body mass index between 30 - 32 kg/m2, but has a body composition \<25% fat -for men and \<35% for women will be accepted into the study
- has been weight stable for the past three months (defined as less than a 5% variation in body -mass over this time)
- is determined to be healthy through completion of a health history questionnaire
Exclusion
- Are currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, - renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- are currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
- report having used anabolic steroids within the past 30 days
- report have used any illicit or recreational drugs within the past 30 days
- report the intake of any prescription or over-the-counter medications (i.e., antibiotics) that may impact study outcomes
- report the current use of any dietary supplements known to impact digestion or sleep quality for the past 30 days
- report already taking a probiotic within the past 30 days
- have been actively trying to lose weight
- are currently following a ketogenic or low carbohydrate diet within the past 30 days
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05343533
Start Date
July 17 2019
End Date
January 1 2022
Last Update
April 25 2022
Active Locations (1)
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1
Lindenwood University
Saint Charles, Missouri, United States, 63301