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Evaluating Synbiotic, Probiotic, or Placebo for Gut Health and Cardiometabolic Health

This study is looking at how different dietary supplements affect your gut health and heart health. Researchers want to see if taking a Synbiotic (Plexus® Triplex), a commercially-available Probiotic, or a placebo (an inactive substance) for 30 days can improve your gut bacteria, blood pressure, and body composition. They will measure changes in your gut bacteria (diversity and count) and short chain fatty acids (SCFAs) at the start, 15 days, and 30 days into the study. You might be able to join if you are a healthy adult between 18 and 60 years old, with stable weight and no uncontrolled chronic diseases. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study comparing three different groups (Synbiotic, Probiotic, or Placebo) in a randomized, double-blind design with 60 planned participants.
What's involved
Participants will take a dietary supplement for 30 days, with measurements of gut health taken at the start, 15 days, and 30 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days, with final measurements taken at that time.

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NCT06544915

Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial

Recruiting
NAAges 18–60InterventionalBasic science
Skidmore College
~60 participants
Updated 2024-08-09 on ClinicalTrials.gov
What's tested:Synbiotic, Probiotic, Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gut microbial diversity
Measured over Baseline, 15 days, 30 days
+2 more outcomes measured

Conditions

Blood Pressure, Body Composition, Immune Function

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Blood Pressure FindingBody PositionImmune System Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Stephen J Ives, PhD · PRINCIPAL_INVESTIGATOR · Skidmore College

Who to contact

Steve Ives, PhD
[email protected]
5185808366
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Given the focus of the study those who are currently, or have recently used (\<3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut/bowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (\<8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (\<1yr) with an eating disorder or food allergies will also be excluded.

What this trial measures

  • Gut microbial diversityBaseline, 15 days, 30 days

    alpha- and beta-diversity

  • Gut microbial countBaseline, 15 days, 30 days

    Gut microbial species identification and quantification

  • Short Chain fatty acidsBaseline, 15 days, 30 days

    Short Chain Fatty Acid concentration