Davis, California 95616


Purpose:

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.


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 - 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


NCT ID:

NCT03785860


Primary Contact:

Jea Woo Kang
Phone: (530) 752-3973
Email: jwkkang@ucdavis.edu


Backup Contact:

N/A


Location Contact:

Davis, California 95616
United States

Jea Woo Kang
Phone: 530-752-3973
Email: jwkkang@ucdavis.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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