Status:
COMPLETED
The Effects of Dietary Fiber on the Gut Microbiome and HDL Particles of Human Subjects
Lead Sponsor:
University of California, Davis
Conditions:
Gut Microbiota
Eligibility:
All Genders
18-45 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03785860
Start Date
May 13 2019
End Date
December 23 2019
Last Update
January 8 2021
Active Locations (1)
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1
University of California, Davis Department of Nutrition
Davis, California, United States, 95616