Actively Recruiting
Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial
Led by Skidmore College · Updated on 2024-08-09
60
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.
CONDITIONS
Official Title
Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 60 years
- Weight stable within plus or minus 4.4 pounds for over 6 months
- Relatively healthy without uncontrolled chronic diseases such as cardiovascular, metabolic, or pulmonary conditions
- Having one or fewer positive cardiovascular disease risk factors as defined by the American College of Sports Medicine/American Heart Association
- Fully vaccinated against COVID-19 with booster according to institutional policy
- Women included without controlling for menstrual cycle phase but with documentation for analysis
You will not qualify if you...
- Current or recent (within 3 months) use of oral antibiotics
- Diagnosed irritable bowel syndrome or other gut/bowel disorders like short bowel syndrome
- Having two or more cardiovascular disease risk factors
- Uncontrolled or overt cardiovascular, pulmonary, or metabolic diseases including Diabetes Mellitus
- Recent blood donation within 8 weeks
- Current cancer or cancer treatment
- Women who are pregnant, breastfeeding, trying to conceive, or amenorrheic not related to menopause or contraceptive use
- Treatment with levothyroxine for hypothyroidism
- Severe illness or compromised immune system, including use of immune suppressants or chronic viral infections
- Diagnosis of eating disorder or food allergies within the past year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Skidmore College
Saratoga Springs, New York, United States, 12866
Actively Recruiting
Research Team
S
Steve Ives, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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