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



Status:Recruiting
Healthy:No
Age Range:18 - 45
Updated:4/3/2019
Start Date:April 1, 2019
End Date:October 25, 2019
Contact:Jea Woo Kang
Email:jwkkang@ucdavis.edu
Phone:(530) 752-3973

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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.


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

- Smoker

- 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

- Irritable bowel syndrome, celiac disease, or any inflammatory bowel disease (including
Crohn's Disease, and/or Ulcerative colitis)

- Any immunosuppression symptoms at any point during the study or study enrollment

- Consumption of >1 alcoholic drink/day or frequent binge drinking (>3 alcoholic drinks
in one episode) > 1 day per month

- Plans to change or recent significant changes in lifestyle (e.g. diet or exercise
routine, major travel, etc)

- Recent weight fluctuations (greater than 10% in the last six months)

- Regular use of over-the-counter pain medications (>1/week)

- Taking prescription lipid medications (e.g. statins) or other supplements known to
alter lipoprotein metabolism such as isoflavones

- Recent medical procedure such as surgery within the last 6 months

- Any changes in the above during the course of the study
We found this trial at
1
site
1 Shields Ave
Davis, California 95616
Principal Investigator: Angela Zivkovic, PhD
Phone: 530-752-3973
?
mi
from
Davis, CA
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