HypertensionNCT07515443
The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health
A study testing Synbiotic in people with Hypertension and Gut Dysbiosis, run by Southern Utah University at 1 site in United States.
Trial summary
The purpose of this study is to see the effect of 30 days of synbiotic vs. probiotic supplementation (usingJuice+ nutrition products) on body weight, metabolism, cardiovascular health, and gut health. This study will provide information for future studies and how such supplementation might influence health long term. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Gut Dysbiosis, Overweight , Obesity
- What is being tested?
- Synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included participants must be healthy, weight stable (± 4.4 lb for > 6 months prior), and 18 to 60 years of age.
- Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 2 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine/American Heart Association Criteria [18] and presented in the table 1 below.
- Participants will be screened for eligibility by a health history form (Appendix A) in person before baseline measurements are made (Figure 1).
- To ensure greater inclusion, ecological validity, and representation, women will be included in this study; however, we will not control for the menstrual cycle phase, but will document for possible statistical consideration.
Who cannot join
- 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 [19].
- Subjects who present with more than 2 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 with severe illness or compromised or suppressed immune system (e.g. taking immunosuppressants, chronic viral infection or treatment) will be excluded [20]. Anyone recently diagnosed (<1yr) with an eating disorder will also be excluded.
- Finally, anyone with food allergies should be cautioned but those with known sensitivity to wheat, acacia gum, stevia, maltodextrin, or rice flour should not participate and will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double-Blind Placebo-Controlled Trial
The purpose of this study is to see the effect of 30 days of synbiotic vs. probiotic supplementation (usingJuice+ nutrition products) on body weight, metabolism, cardiovascular health, and gut health. This study will provide information for future studies and how such supplementation might influence health long term. You are being asked to participate because you are 18-60 years old, relatively healthy 1 or fewer risk factors for cardiovascular disease), and have been weight stable (weight within ±4.4 lbs) for at least 6 months.People who present with 2 or more cardiovascular disease risk factors (we will ask you this information) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will not be able to participate. Those who have been diagnosed and/or are being treated for cancer will not be able to participate. Anyone recently (<1yr) diagnosed with an eating disorder is also not eligible to participate. Women who are currently pregnant, breastfeeding, attempting to conceive, or without a period will not be allowed to participate. 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. 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 Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Please discuss any other potential food allergies with the research team, as food allergies will disqualify you from participating. About 48 people will take part in this research.
Read the detailed description
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with a novel Synbiotic (JuicePlus), or 2) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight, and body composition in healthy individuals.
Specific Aim 1. Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity), short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity as a result of a novel synbiotic vs. placebo control.
Specific Aim 2. Document the functional changes in cardiometabolic health-related parameters; specifically, heart rate, heart rate variability (HRV), blood pressure (central and peripheral), vascular stiffness (augmentation index, AIx, and pulse wave velocity, PWV), body weight and composition, blood glucose and lipids as a result of a novel synbiotic vs. placebo control.
Specific Aim 3. Characterize the impact of synbiotic vs. placebo control on perceptions of gut health (questionnaire), and mood states, given the gut-brain axis.
- Conditions
- Hypertension, Gut Dysbiosis, Overweight , Obesity
- Being tested
- Synbiotic, Placebo
- Medical subject headings
- Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
daily supplementation of snybiotic drink packet and capsule of multistrain probiotic
PlaceboDietary supplement
daily placebo drink packet and capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 30 day supplementation of synbiotic Receives: Dietary Supplement: Synbiotic |
| Control group | Placebo comparator | 30 day supplementation of placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome diversity and total bacteria
Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity).
Measured: 30 days
Blood biomarkers
Blood markers of short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity
Measured: 30 days
Secondary outcomes (1)
Hypertension
Assess changes in peripheral blood pressure via an oscillometric cuff
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Utah University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515443
- Sponsor's protocol ID
- 30-052025a
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07515443
- Acronym / sponsor ID
- 30-052025a
- Conditions
- Hypertension, Gut Dysbiosis, Overweight , Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Southern Utah UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see the effect of 30 days of synbiotic vs. probiotic supplementation (usingJuice+ nutrition products) on body weight, metabolism, cardiovascular health, and gut health. This study will provide information for future studies and how such supplementation might influence health long term. You are being asked to participate because you are 18-60 years old, relatively healthy 1 or fewer risk factors for cardiovascular disease), and have been weight stable (weight within ±4.4 lbs) for at least 6 months.People who present with 2 or more cardiovascular disease risk factors (we will ask you this information) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will not be able to participate. Those who have been diagnosed and/or are being treated for cancer will not be able to participate. Anyone recently (<1yr) diagnosed with an eating disorder is also not eligible to participate. Women who are currently pregnant, breastfeeding, attempting to conceive, or without a period will not be allowed to participate. 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. 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 Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Please discuss any other potential food allergies with the research team, as food allergies will disqualify you from participating. About 48 people will take part in this research.
Detailed description
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with a novel Synbiotic (JuicePlus), or 2) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight, and body composition in healthy individuals.
Specific Aim 1. Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity), short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity as a result of a novel synbiotic vs. placebo control.
Specific Aim 2. Document the functional changes in cardiometabolic health-related parameters; specifically, heart rate, heart rate variability (HRV), blood pressure (central and peripheral), vascular stiffness (augmentation index, AIx, and pulse wave velocity, PWV), body weight and composition, blood glucose and lipids as a result of a novel synbiotic vs. placebo control.
Specific Aim 3. Characterize the impact of synbiotic vs. placebo control on perceptions of gut health (questionnaire), and mood states, given the gut-brain axis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Synbiotic30 day supplementation of synbiotic |
| Control group | Placebo comparator | Dietary Supplement: Placebo30 day supplementation of placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be included participants must be healthy, weight stable (± 4.4 lb for > 6 months prior), and 18 to 60 years of age.
- Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 2 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine/American Heart Association Criteria [18] and presented in the table 1 below.
- Participants will be screened for eligibility by a health history form (Appendix A) in person before baseline measurements are made (Figure 1).
- To ensure greater inclusion, ecological validity, and representation, women will be included in this study; however, we will not control for the menstrual cycle phase, but will document for possible statistical consideration.
Key exclusion criteria (5 listed)
- 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 [19].
- Subjects who present with more than 2 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 with severe illness or compromised or suppressed immune system (e.g. taking immunosuppressants, chronic viral infection or treatment) will be excluded [20]. Anyone recently diagnosed (<1yr) with an eating disorder will also be excluded.
- Finally, anyone with food allergies should be cautioned but those with known sensitivity to wheat, acacia gum, stevia, maltodextrin, or rice flour should not participate and will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbioticdaily supplementation of snybiotic drink packet and capsule of multistrain probiotic | Dietary supplement | Treatment group |
| Placebodaily placebo drink packet and capsule | Dietary supplement | Control group |
Primary outcome
Gut microbiome diversity and total bacteria
Time frame: 30 days
Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity).
Blood biomarkers
Time frame: 30 days
Blood markers of short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity
1 secondary outcome
Hypertension
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Hypertension and Gut Dysbiosis, run by Southern Utah University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome diversity and total bacteria (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.