Metabolic SyndromeNCT03201068
Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome
A study testing Probiotic supplement in people with Metabolic Syndrome and Microbiome, run by Stanford University at 1 site in United States.
Trial summary
This study will define the impact of a probiotic supplement on microbiome, immune system, and metabolic syndrome. This study will determine the degree to which a probiotic supplement can 1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota composition and function, 3) impact microbiota… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Microbiome, Immune Function
- What is being tested?
- Probiotic supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 4 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and older
- Must have metabolic syndrome as defined by having at least 2 of the 5 criteria per either ATP III guidelines OR International Diabetes Federation (IDF) guidelines:
- ATP III guidelines:
- Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
- Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
- Serum high-density lipoprotein (HDL) cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol
Show all 16Show fewer
- Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
- Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
- International Diabetes Federation Guidelines:
- Increased waist circumference, with ethnic-specific waist circumference cut-points:
- White and all other ethnic groups - Men ≥ 94 cm; Women ≥ 80 cm South Asians, Chinese, and Japanese - Men ≥ 90 cm; Women ≥ 80 cm
- PLUS any two of the following:
- Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides
- HDL cholesterol <40 mg/dL (1.03 mmol/L) in men or <50 mg/dL (1.29 mmol/L) in women, or treatment for low HDL
- Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension
- FPG ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type 2 diabetes; an oral glucose tolerance test is recommended for patients with an elevated fasting plasma glucose, but not required.
Who cannot join
- Body Mass Index (BMI) ≥ 40
- LDL >160 mg/dL.
- Vital signs outside of acceptable range at Screening Visit: blood pressure >159/99, oral temperature ≥ 100°F, pulse >100.
- Use of any of the following drugs within the last 6 months:systemic antibiotics (must be discontinued and avoided for 2 months prior to the study start), antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents;
- Use of large doses of commercial probiotics consumed within the last 6 months (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (must be discontinued and avoided for one month prior to the study start). Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome
This study will define the impact of a probiotic supplement on microbiome, immune system, and metabolic syndrome. This study will determine the degree to which a probiotic supplement can 1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota composition and function, 3) impact microbiota metabolites, short-chain fatty acids-potential normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling.
Read the detailed description
The centrality of the gut microbiota to human health has emerged in just the last decade, with the last three years implicating our modern, deteriorated gut microbiota in numerous chronic diseases. It is likely dietary changes in the last half-century consistent with adoption of the Western diet have had an adverse impact on the gut microbiota. A critically important next step in this field of research is to identify how different probiotic supplements can potentially restore the microbiota in alignment with the optimization of human health, particularly in regard to the reversal or prevention of chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast the amount of increase in microbiota diversity and related metabolic output achievable following consumption of a probiotic supplement commonly available to the general population. The results could contribute to dietary recommendations for reversing the chronic disease epidemics of westernization.
- Conditions
- Metabolic Syndrome, Microbiome, Immune Function, Inflammation
- Being tested
- Probiotic supplement, Placebo
- Medical subject headings
- Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementDietary supplement
Also called Renew Life Formulas, Inc
Probiotic supplement capsule
PlaceboDietary supplement
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplement | Experimental | Renew Life Formulas, Inc Receives: Dietary Supplement: Probiotic supplement |
| Placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome parameters: Waist Circumference, Blood pressure, Triglycerides, HDL-cholesterol, and Fasting Glucose.
10-week change from Baseline (week 4) in the number of subjects presenting 3 of the 5 parameters for metabolic syndrome (waist circumference, blood pressure, triglycerides, HDL-cholesterol, and fasting glucose) at 14 weeks (end of intervention).
Measured: Baseline (week 4) and end of intervention (week 14)
Secondary outcomes (5)
Microbiota composition
10-week change from baseline (week 4) in 16S rRNA enumeration at 14 weeks (end of intervention), determined using Illumina-based sequencing.
Measured: Baseline (week 4) and end of intervention (week 14)
Microbiota metabolites
10-week change from Baseline (week 4) in short-chain fatty acids (SCFA) at 14 weeks (end of intervention).
Measured: Baseline (week 4) and end of intervention (week 14)
Cytokines
10-week change from Baseline (week 4) in cytokines at 14 weeks (end of intervention).
Measured: Baseline (week 4) and end of intervention (week 14)
Chemokines
10-week change from Baseline (week 4) in chemokines at 14 weeks (end of intervention).
Measured: Baseline (week 4) and end of intervention (week 14)
hs-C Reactive Protein (CRP)
10-week change from Baseline (week 4) in hs-CRP at 14 weeks (end of intervention).
Measured: Baseline (week 4) and end of intervention (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start14 Sep 2017
- Primary completion16 Nov 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Clorox Company
- Responsible party
- Principal investigator, Justin L. Sonnenburg, Stanford University
- Investigators
- Christopher D Gardner, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201068
- Sponsor's protocol ID
- 41697
- Status last verified
- Feb 2023
- First submitted
- 23 Jun 2017
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wastyk HC, Perelman D, Topf M, Fragiadakis GK, Robinson JL, Sonnenburg JL, Gardner CD, Sonnenburg ED. Randomized controlled trial demonstrates response to a probiotic intervention for metabolic syndrome that may correspond to diet. Gut Microbes. 2023 Jan-Dec;15(1):2178794. doi: 10.1080/19490976.2023.2178794.
PubMed 36803658
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03201068
- Acronym / sponsor ID
- 41697
- Conditions
- Metabolic Syndrome, Microbiome, Immune Function, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Clorox Company
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 28 Jun 2017 (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.
This study will define the impact of a probiotic supplement on microbiome, immune system, and metabolic syndrome. This study will determine the degree to which a probiotic supplement can 1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota composition and function, 3) impact microbiota metabolites, short-chain fatty acids-potential normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling.
Detailed description
The centrality of the gut microbiota to human health has emerged in just the last decade, with the last three years implicating our modern, deteriorated gut microbiota in numerous chronic diseases. It is likely dietary changes in the last half-century consistent with adoption of the Western diet have had an adverse impact on the gut microbiota. A critically important next step in this field of research is to identify how different probiotic supplements can potentially restore the microbiota in alignment with the optimization of human health, particularly in regard to the reversal or prevention of chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast the amount of increase in microbiota diversity and related metabolic output achievable following consumption of a probiotic supplement commonly available to the general population. The results could contribute to dietary recommendations for reversing the chronic disease epidemics of westernization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplement | Experimental | Dietary Supplement: Probiotic supplementRenew Life Formulas, Inc |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18 and older
- Must have metabolic syndrome as defined by having at least 2 of the 5 criteria per either ATP III guidelines OR International Diabetes Federation (IDF) guidelines:
- Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
- Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
- Serum high-density lipoprotein (HDL) cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol
Key exclusion criteria (5 listed)
- Body Mass Index (BMI) ≥ 40
- LDL >160 mg/dL.
- Vital signs outside of acceptable range at Screening Visit: blood pressure >159/99, oral temperature ≥ 100°F, pulse >100.
- Use of any of the following drugs within the last 6 months:systemic antibiotics (must be discontinued and avoided for 2 months prior to the study start), antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents;
- Use of large doses of commercial probiotics consumed within the last 6 months (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (must be discontinued and avoided for one month prior to the study start). Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
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 |
|---|---|---|
| Probiotic supplementAlso: Renew Life Formulas, IncProbiotic supplement capsule | Dietary supplement | Probiotic supplement |
| PlaceboPlacebo capsule | Dietary supplement | Placebo |
Primary outcome
Metabolic syndrome parameters: Waist Circumference, Blood pressure, Triglycerides, HDL-cholesterol, and Fasting Glucose.
Time frame: Baseline (week 4) and end of intervention (week 14)
10-week change from Baseline (week 4) in the number of subjects presenting 3 of the 5 parameters for metabolic syndrome (waist circumference, blood pressure, triglycerides, HDL-cholesterol, and fasting glucose) at 14 weeks (end of intervention).
5 secondary outcomes
Microbiota composition
Time frame: Baseline (week 4) and end of intervention (week 14)
Microbiota metabolites
Time frame: Baseline (week 4) and end of intervention (week 14)
Cytokines
Time frame: Baseline (week 4) and end of intervention (week 14)
Chemokines
Time frame: Baseline (week 4) and end of intervention (week 14)
hs-C Reactive Protein (CRP)
Time frame: Baseline (week 4) and end of intervention (week 14)
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 24 Feb 2023.
- Background: PubMed 36803658Wastyk HC, Perelman D, Topf M, Fragiadakis GK, Robinson JL, Sonnenburg JL, Gardner CD, Sonnenburg ED. Randomized controlled trial demonstrates response to a probiotic intervention for metabolic syndrome that may correspond to diet. Gut Microbes. 2023 Jan-Dec;15(1):2178794. doi: 10.1080/19490976.2023.2178794.
- Study description and summary of resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christopher D Gardner, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplement in people with Metabolic Syndrome and Microbiome, run by Stanford 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 16 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 24 Feb 2023. 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?
Metabolic syndrome parameters: Waist Circumference, Blood pressure, Triglycerides, HDL-cholesterol, and Fasting Glucose. (time frame: Baseline (week 4) and end of intervention (week 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201068, which also lists 1 linked publication.
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 24 Feb 2023.