Metabolic SyndromeNCT03275662
Fermented and Fiber-rich Food (FeFiFo) Study
A study testing Dietary Fiber and Fermented Foods in people with Metabolic Syndrome and Microbiome, run by Stanford University at 1 site in United States.
Trial summary
The primary objective is to contrast the degree to which increased consumption of dietary fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can impact microbiota production of short-chain fatty acids (SCFA), potential normalizers of metabolic and immune dysfunction, in obese and… 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?
- Dietary Fiber and Fermented Foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2016to 2 Jun 2017
- 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, both genders, all ethnic backgrounds
- Healthy subjects willing and able to provide blood, as well as stool specimens
- Able to provide signed and dated informed consent.
Who cannot join
- Body Mass Index higher than 40.
- Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure greater than 160/100, oral temperature greater than 100 degrees F, pulse greater than 100.
- Use of any of the following drugs within the last 6 months:
- systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
- oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
- cytokines;
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- methotrexate or immunosuppressive cytotoxic agents;
- large doses of commercial probiotics consumed (greater than or equal to 10e8 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component.
- consumption of > 20 g fiber/day and > 7 servings of fermented foods per week.
- Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
- Positive test for HIV, HBV or HCV.
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency ( primary or acquired) including HIV infection.
- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- History of active uncontrolled gastrointestinal disorders or diseases including:
- inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
- irritable bowel syndrome (IBS) (moderate-severe);
- persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
- chronic constipation.
- Female who is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Microbiota-targeted Dietary Strategies to Reduce Inflammatory Markers of Americans: High Fiber vs Fermented Food
The primary objective is to contrast the degree to which increased consumption of dietary fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can impact microbiota production of short-chain fatty acids (SCFA), potential normalizers of metabolic and immune dysfunction, in obese and non-obese adults.
Read the detailed description
The gut microbiota is central to human health, and the modern, industrialized gut microbiota has been linked to numerous chronic diseases that are driven by inflammation. 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 dietary interventions can potentially restore healthy features of the gut microbiota in alignment with the optimization of human health. Dietary interventions that target the microbiota and reduce inflammation may reverse or prevent chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast inflammatory markers in blood with the amount of increase in microbiota diversity and related metabolic output achievable by two dietary approaches 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
- Dietary Fiber, Fermented Foods
- 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.
Dietary FiberBehavioural
Fermented FoodsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fiber Group | Experimental | Participants are asked to increase their usual dietary fiber intake by 20 grams/day. Receives: Behavioral: Dietary Fiber |
| Fermented Foods Group | Experimental | Participants are asked to consume 6 servings of fermented foods per day. Receives: Behavioral: Fermented Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune profile: Cytokine Response Score (CRS)
Change from baseline in CRS at 10 weeks
Measured: Baseline and 10 weeks
Secondary outcomes (2)
Microbiota metabolites: short-chain fatty acids (SCFA)
Change from baseline in short-chain fatty acids (SCFA) at 10 weeks.
Measured: Baseline and 10 weeks
Microbiota composition
Change from baseline in 16S rRNA enumeration at 10 weeks, determined using Illumina-based sequencing.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start29 Aug 2016
- Primary completion2 Jun 2017
- Study completion2 Jun 2017
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin L. Sonnenburg, Stanford University
- Investigators
- Justin L Sonnenburg, PhD, Principal investigator, Stanford UniversityChristopher D Gardner, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275662
- Sponsor's protocol ID
- 36643
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2017
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.
PubMed 34256014
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
- Microbiota-targeted Dietary Strategies to Reduce Inflammatory Markers of Americans: High Fiber vs Fermented Food
- ClinicalTrials.gov ID
- NCT03275662
- Acronym / sponsor ID
- 36643
- Conditions
- Metabolic Syndrome, Microbiome, Immune Function, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 7 Sep 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.
The primary objective is to contrast the degree to which increased consumption of dietary fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can impact microbiota production of short-chain fatty acids (SCFA), potential normalizers of metabolic and immune dysfunction, in obese and non-obese adults.
Detailed description
The gut microbiota is central to human health, and the modern, industrialized gut microbiota has been linked to numerous chronic diseases that are driven by inflammation. 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 dietary interventions can potentially restore healthy features of the gut microbiota in alignment with the optimization of human health. Dietary interventions that target the microbiota and reduce inflammation may reverse or prevent chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast inflammatory markers in blood with the amount of increase in microbiota diversity and related metabolic output achievable by two dietary approaches 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber Group | Experimental | Behavioral: Dietary FiberParticipants are asked to increase their usual dietary fiber intake by 20 grams/day. |
| Fermented Foods Group | Experimental | Behavioral: Fermented FoodsParticipants are asked to consume 6 servings of fermented foods per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 and older, both genders, all ethnic backgrounds
- Healthy subjects willing and able to provide blood, as well as stool specimens
- Able to provide signed and dated informed consent.
Key exclusion criteria (23 listed)
- Body Mass Index higher than 40.
- Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure greater than 160/100, oral temperature greater than 100 degrees F, pulse greater than 100.
- Use of any of the following drugs within the last 6 months:
- Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history or physical examination.
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 |
|---|---|---|
| Dietary Fiber | Behavioural | Fiber Group |
| Fermented Foods | Behavioural | Fermented Foods Group |
Primary outcome
Immune profile: Cytokine Response Score (CRS)
Time frame: Baseline and 10 weeks
Change from baseline in CRS at 10 weeks
2 secondary outcomes
Microbiota metabolites: short-chain fatty acids (SCFA)
Time frame: Baseline and 10 weeks
Microbiota composition
Time frame: Baseline and 10 weeks
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 34256014Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.
- Study description and results summaryLink 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.
Justin L Sonnenburg, PhD principal investigator
Stanford University
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 Dietary Fiber and Fermented Foods 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 3 inclusion and 23 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. 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?
Immune profile: Cytokine Response Score (CRS) (time frame: Baseline and 10 weeks). 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 NCT03275662, 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.