Synbiotic vs Probiotic for Hypertension

(GUTRCT Trial)

Overseen By Steve Ives, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Skidmore College

Must not be taking: Oral antibiotics, Immune suppressants

Disqualifiers: Cancer, Diabetes, Pregnancy, others

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephen J Ives, PhD

Principal Investigator

Skidmore College

Eligibility Criteria

This trial is for healthy individuals who want to see if taking a Synbiotic (Plexus® Triplex), Probiotic, or placebo can affect their gut bacteria and heart health over 30 days. Specific eligibility criteria are not provided.

Inclusion Criteria

I am generally healthy without any unmanaged long-term illnesses.

My menstrual cycle phase is not controlled for this study but will be noted.

I am healthy, my weight has been stable for over 6 months, and I am between 18 and 60 years old.

Exclusion Criteria

I do not have multiple heart disease risks or uncontrolled health conditions, and haven't donated blood recently.

I am not taking levothyroxine for hypothyroidism.

I haven't used oral antibiotics or been diagnosed with gut issues like IBS recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either synbiotic, probiotic, or placebo control over 30 days to evaluate effects on gut microbiome and cardiometabolic health

4 weeks

3 visits (in-person) at baseline, 15 days, and 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Probiotic
• Synbiotic

Trial Overview The study tests the effects of a Synbiotic supplement versus a Probiotic or placebo on gut microbiota and aspects of heart health, weight, and body composition in participants over one month.

Participant Groups

Group I: Synbiotic Experimental Treatment 1 Intervention

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)

Group II: Probiotic Active Control 1 Intervention

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))

Group III: Placebo Placebo Group 1 Intervention

placebo control (4x/day collagen capsules and 2x/day placebo drink mixes (maltodextrin), Plexus)

Probiotic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in United States as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in Canada as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials

20

Recruited

1,100+