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

Conditions

• Blood Pressure, Body Composition, Immune Function

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Synbiotic, Probiotic, Placebo — DIETARY_SUPPLEMENT
  Use of dietary supplements to improve gut microbiome and cardiometabolic health

Study Details

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.

Key Dates

Start date

Jul 23, 2024

Status verified

Aug 2024

Primary completion

Jan 1, 2025

Completion

Jan 1, 2025

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Synbiotic
  synbiotic (Triplex (2x/day Probiotic capsules (2 billion CFU/capsule, ProBio5), 2x/day Capsules of gut supporting micronutrients; magnesium, vitamin c and citrus bioflavonoids (BioCleanse) and 2x/day Pre-biotic drink mixes (Slim Microbiome Activating), Plexus®, Scottsdale, AZ, USA)
• Active Comparator: Probiotic
  probiotic (2x/day probiotic capsules (2 billion CFU/capsules, NOW supplement), 2x/day capsules of collagen (Plexus), and 2x/day placebo drink mixes of corn-based maltodextrin (Plexus))
• Placebo Comparator: Placebo
  placebo control (4x/day collagen capsules and 2x/day placebo drink mixes (maltodextrin), Plexus)

Primary Outcome Measure

Gut microbial diversity [ Time Frame: Baseline, 15 days, 30 days ]

Central Contacts

• Steve Ives, PhD
  5185808366
  [email protected]

Locations (1)

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