The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects

University of California, Davis1 site in 1 country20 target enrollmentMay 13, 2019

ConditionsGut Microbiota

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gut Microbiota
Sponsor: University of California, Davis
Enrollment: 20
Locations: 1
Primary Endpoint: Change in gut microbiota
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this project is to conduct a randomized-order, double-blinded cross-over trial in 20 participants to test the effects of a dietary fiber formulation on gut microbiota composition and short chain fatty acid production, lipid profiles, glucose sensitivity, intestinal permeability, overall gut health, and markers of inflammation.

Registry

clinicaltrials.gov

Start Date

May 13, 2019

End Date

December 23, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of California, Davis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female adults 18-45 years old
•BMI: 23.0-32.0 kg/m2 ("overweight")
•Current diet includes low quantity of fiber, defined as less than approximately 15g/day, or equivalent to approximately 4 servings of fruit, vegetable, legume, or whole grain combined per day, and determined using diet recall.
•Willingness to consume prebiotic fiber drink daily for 4 weeks, and a placebo drink for 4 weeks, as well as a 4-week washout period with no intervention.
•Willingness to provide diet records, blood samples and stool samples (self-collected) biweekly for the duration of the study (7 total collections).
•Willingness to adhere to "diet control period" biweekly (eating the same, self-selected foods and abstaining from alcohol each day for 3 days prior to each stool collection/blood draw).
•General bowel movement frequency of at least once every three days and maximum of two times per day.

Exclusion Criteria

•A plan to or desire to lose weight
•Anemia and difficulty with blood draws
•Currently, within previous 6 weeks of the study, or during the study taken probiotic or prebiotic formulations (food products considered to have these properties in their natural or unadulterated forms are acceptable).
•Antibiotic use during the study or within 6 months prior to study commencement.
•Medication: statins, blood pressure medications, other prescription medications
•Pregnant, planning to be pregnant or breast feeding at any point during the study or study enrollment.
•Start or change in use of hormonal birth control in the last 6 months or plans to change or start use of hormonal birth control during the study period
•Allergies to any prebiotic or placebo ingredients - Prebiotic ingredients: Resistant Tapioca Starch, Fructooligosaccharide, Sugarcane Fiber, Agave Inulin, Gum Arabic, Xanthan Gum, Apple Powder, Raspberry Powder, Blueberry Powder / Placebo Blend: Rice Flour, Xanthan Gum, Grape Powder, Plum Powder
•Illness (flu/cold in the last two weeks)
•Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, hypertension, cancer, or previous cardiovascular events

Outcomes

Primary Outcomes

Change in gut microbiota

Time Frame: One month time frame for dietary fiber to affect the gut microbiota of participants

Gene sequencing and data analysis will be conducted to explore the change in gut microbial abundance and diversity. Specifically, the primary outcome measure will be change in the proportion of Bifidobacterium, Lactobacillus, and/or Akkermansia muciniphila.