Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06544915

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

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Skidmore College

Saratoga Springs, New York, United States, 12866

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here