Status:
NOT_YET_RECRUITING
Next-Generation Synbiotic in Individuals With Overweight or Obesity
Lead Sponsor:
Texas Christian University
Collaborating Sponsors:
Pendulum Therapeutics
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on...
Detailed Description
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibio...
Eligibility Criteria
Inclusion
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Exclusion
- are following a vegetarian, vegan, carnivore, or keto diet
- currently taking metformin, GLP-1 agonists, insulin, or fiber
- have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- pregnant, planning pregnancy during the study period, or lactating
- have a history of inflammatory bowel disease, colon cancer, or chronic polyps
- have been diagnosed with type 1 or type 2 diabetes
- have active cancer
- are currently participating in a weight loss intervention (dietetic or medication)
- have used antibiotics, antifungals, or antivirals in the past 3 months
- have had a history of recent (within 30 days) diarrhea illness
- have a known allergy to any component of the study product
- have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
- have had \>10% weight variation in the past 6 months
- have had any bariatric surgery
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06213480
Start Date
January 10 2024
End Date
May 20 2025
Last Update
January 19 2024
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