Fermented and Fiber-rich Food (FeFiFo) Study

NCT03275662 | Completed

• 1 other identifier: 36643
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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 non-obese adults.

Conditions

Metabolic Syndrome; Microbiome; Immune Function; Inflammation

Outcome Measures

Primary Outcomes (1)

• Immune profile: Cytokine Response Score (CRS)

  Change from baseline in CRS at 10 weeks

  Baseline and 10 weeks

Secondary Outcomes (2)

• Microbiota metabolites: short-chain fatty acids (SCFA)

  Baseline and 10 weeks

• Microbiota composition

  Baseline and 10 weeks

Study Arms (2)

Fiber Group

EXPERIMENTAL

Participants are asked to increase their usual dietary fiber intake by 20 grams/day.

Behavioral: Dietary Fiber

Fermented Foods Group

EXPERIMENTAL

Participants are asked to consume 6 servings of fermented foods per day.

Behavioral: Fermented Foods

Interventions

Dietary Fiber BEHAVIORAL

Fiber Group

Fermented Foods BEHAVIORAL

Fermented Foods Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 34256014 BACKGROUND

Related Links

• Study description and results summary

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Interventions

Dietary Fiber; Fermented Foods

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Justin L Sonnenburg, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Christopher D Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Microbiology and Immunology

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 7, 2017
• Study Start: August 29, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)