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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COMPLETED
34 participants
OBSERVATIONAL
2020-11-10
2022-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Lean BMI (19-25)
Synbiotic
Synbiotic dietary supplement in capsule form
Obese BMI (30-35)
Synbiotic
Synbiotic dietary supplement in capsule form
Interventions
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Synbiotic
Synbiotic dietary supplement in capsule form
Eligibility Criteria
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Inclusion Criteria
* Age 18-45 years old
* subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
* willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)
Exclusion Criteria
* diabetes
* kidney disorders
* history of cardiac disease and medications for cardiac disease
* use of statins and antihypertensive drugs
* inflammatory bowel disease
* irritable bowel syndrome
* history of small intestinal bacterial overgrowth
* history of intestinal surgery, excluding hernia repair and appendectomy
* active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
* immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
* abnormal liver or kidney function as measured by routine serum chemistry testing
* severe anemia or significant white blood cell or platelet abnormalities
* no additional blood or blood product donations during study
18 Years
45 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Gail Cresci
Director Nutrition Research within Center for Human Nutrition
Principal Investigators
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Gail Cresci
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Kassandra Spates-Harden
Cleveland, Ohio, United States
Countries
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Other Identifiers
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IRB #19-601
Identifier Type: -
Identifier Source: org_study_id