60 Participants Needed

Synbiotic vs Probiotic for Hypertension

(GUTRCT Trial)

SI
Overseen BySteve Ives, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different supplements affect heart health, weight, and gut health. Participants will take either a synbiotic (a mix of probiotics and prebiotics), a probiotic, or a placebo for 30 days. The study aims to determine which of these options, if any, can improve health markers in individuals without major chronic illnesses. Those who are healthy, have stable weight, and have one or no heart disease risk factors might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to the scientific understanding of supplements and their potential health benefits.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated for hypothyroidism with levothyroxine, you will be excluded from the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has examined synbiotic treatments for safety and effectiveness. Studies have shown that synbiotics can lower the systolic blood pressure by an average of 3.02 mmHg, suggesting potential heart health benefits without major safety concerns.

For probiotics, strong evidence supports their safety. Research indicates they can reduce high blood pressure symptoms without significant side effects. Probiotics improve gut health and ease stress in blood vessels. Overall, both synbiotic and probiotic treatments are well-tolerated.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for hypertension because they explore innovative ways to manage blood pressure using gut health. The Synbiotic treatment combines probiotics with prebiotics and micronutrients like magnesium and vitamin C, aiming to improve gut health and potentially lower blood pressure through a holistic approach. On the other hand, the Probiotic treatment focuses on the beneficial effects of probiotics alone, using collagen and placebo drink mixes to support the body's natural balance. Unlike standard hypertension treatments that often rely on medications affecting the heart or blood vessels, these treatments target the gut microbiome, offering a novel and potentially more natural means to manage hypertension.

What evidence suggests that this trial's treatments could be effective for hypertension?

This trial will compare the effects of synbiotics and probiotics on hypertension. Research has shown that synbiotics, which participants in this trial may receive, can help lower blood pressure. One study found that people who took synbiotics had lower blood pressure readings than those who did not. Another study combined results from four different trials and found that synbiotics led to a noticeable drop in blood pressure.

For probiotics, another treatment option in this trial, the evidence on their ability to lower blood pressure remains less clear. While probiotics benefit gut health, there is little direct proof that they reduce blood pressure. Overall, synbiotics appear more promising for managing blood pressure based on current research.678910

Who Is on the Research Team?

SJ

Stephen J Ives, PhD

Principal Investigator

Skidmore College

Are You a Good Fit for This Trial?

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.
See 2 more

Exclusion Criteria

I am not taking levothyroxine for hypothyroidism.
I do not have multiple heart disease risks or uncontrolled health conditions, and haven't donated blood recently.
I haven't used oral antibiotics or been diagnosed with gut issues like IBS recently.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: SynbioticExperimental Treatment1 Intervention
Group II: ProbioticActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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

🇪🇺
Approved in European Union as Probiotics for:
🇺🇸
Approved in United States as Probiotics for:
🇨🇦
Approved in Canada as Probiotics for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials
20
Recruited
1,100+

Citations

The effects of synbiotic supplementation on blood pressure ...The study aimed to compare the effect of synbiotic and placebo on blood pressure and pregnancy duration as primary outcomes, and other pregnancy outcomes.
The effect of synbiotics on liver enzymes, obesity indices ...The effects of synbiotics supplementation on blood pressure (SBP and DBP). Pooling data on 4 studies revealed that synbiotics supplementation significantly ...
Efficacy of the Synbiotic Supplementation on the Metabolic ...The outcomes of the current trial demonstrated that synbiotic supplementation caused a significant fall in FBG concentration but had no effects on insulin level ...
The Effect of Synbiotic Consumption on Serum NTproBNP, ...We observed a decrease in systolic and diastolic blood pressure in the synbiotic group and an increase in systolic and diastolic blood pressure ...
Prebiotics Improve Blood Pressure Control by Modulating ...Conclusions: Prebiotic supplementation is a promising strategy to reestablish BP homeostasis in hypertensive patients. Benefits are likely mediated through ...
Probiotics: functional food ingredients with the potential to ...Probiotics can reduce hypertension symptoms through four mechanisms: regulating vascular oxidative stress, producing short-chain fatty acids, restoring ...
Is There Evidence to Support Probiotic Use for Healthy ...We concluded that there is sufficient evidence of efficacy and safety for clinicians and consumers to consider using specific probiotics for some indications – ...
Clinical Evidence on the Potential Beneficial Effects of ...Consuming probiotics resulted in a little reduction in blood pressure, with the impact being more pronounced if the basal blood pressure was elevated, according ...
Probiotics - Health Professional Fact SheetProbiotics overview for health professionals. Research food and supplement sources, health effects, safety, selection, and use here.
Gut Microbiome and Neuroinflammation in HypertensionThis review highlights a hypothesis for hypertension that suggests alternative mechanisms for blood pressure elevation and maintenance.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security