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The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy.
The main questions it aims to answer are:
Participants will be in one of two groups:
Fiber fermentation in the colon produces short chain fatty acids (SCFA) and alters the microbial composition and activity. These effects may be mechanisms linking a high-fiber diet to improved health. However, different people may respond to dietary fiber differently and the variability in early, dietary-induced SCFA concentration changes has not been established. This lack of basic understanding in individual patterns of microbial SCFA production significantly limits efforts in the field of Precision Nutrition designed to target dietary strategies to improve health and advance lifestyle treatments in healthcare in the future. In this project, the central hypothesis is that the mechanisms by which dietary fiber provide metabolic benefits include a direct physical effect to improve fasting glucose and lipids and an effect related to increasing SCFA concentration. These are the ideas being tested in this study.
Using fiber derived from peas in a two-week human feeding intervention, Aim 1 will quantitate the variability in high-fiber-induced change in microbial composition and SCFA production by specifically testing the hypothesis that Following successful colonoscopy bowel prep, variability in the reduction in microbial species will be very small, while repopulation after a standardized high-fiber diet will be characterized by larger differences between individuals with regard to the quantity of bifidobacterial and the Firmicutes/ Bacteroidetes ratio.
Aim 2 will quantitate the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (SCFA, BMI, sex, starting glucose level) for these changes by testing the hypothesis that a two-week, high-fiber diet will result in lower plasma glycemia and triglycerides. Participants (n=30) who have undergone a health-screening colonoscopy (HSC) are fed a high-fiber diet for 14 days. Fecal samples are collected before the colonoscopy and on days 1, 7 and 14 after the colonoscopy during high-fiber feeding. On day 1 and 14, the subject visits the clinical unit for a fasting blood draw (for measurement of glucose, lipids, and plasma SCFA), surveys and questionnaires.
A control arm will also be included as part of this study. The purpose of the control arm is to quantitate the variability in microbial composition and SCFA production from an ad libitum diet of participants. Instead of providing a high-fiber diet, the repopulation of the gut microbiome will be observed when participants eat a diet that is of their choosing. A series of food records and fecal samples pre- and post-procedure will be collected. Figure 2 shows the protocol of this arm. Food records will be collected: pre-procedure, days 0 (procedure day), 1, 2, 4, 7, 10, 13. Fecal collection will be collected: pre-procedure, 3, 5, 8, 11, 14. This arm will not include the blood collection or DEXA scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Fiber | Experimental | Subjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured |
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| Control | No Intervention | Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fiber | Dietary Supplement | A pea fiber supplement is added to a diet of regular foods. Participants receive 25g fiber daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Variability in microbial composition as measured by 'alpha diversity' | Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14). Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14). Variability in microbial composition refers to how many different kinds of microbes are present in the fecal sample. We are testing the possibility that the more kinds of microbes, the healthier the person. The higher the measure the alpha diversity, the greater the number of different microbes. | 2 weeks |
| Concentration of SCFA | Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14). Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose concentration (mg/dL) | Measure changes in fasting blood glucose concentration following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up. | 2 weeks |
| Blood lipid concentation (total cholesterol, LDLc, HDLc) (mg/dL) |
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Intervention Arm
Inclusion Criteria:
Men and women
Age 45-65y: the average age of people referred for a screening colonoscopy
BMI ≥20.0 or ≤40.0 kg/m2
Weight stable: no fluctuations in body weight of greater than 4 kg in the last 3 months
Scheduled for a health-screening colonoscopy
Willingness to consume a high-fiber diet
Willing to provide blood and fecal samples
Healthy or have one or more characteristics of the metabolic syndrome (but not diabetic) Metabolic syndrome criteria
Subjects are also eligible if they are stably treated with statin drugs, anti-hypertensive medications, and anti-depressants. These are eligible as long as the drug category does not alter appetite, body weight, or the microbiome (if known).
Exclusion Criteria:
Control Arm Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Parks | University of Missouri-Columbia | Principal Investigator |
| Yezaz Ghouri, MD | University of Missouri-Columbia | Principal Investigator |
| Katherene Anguah, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Treatment group: 2 week high fiber diet Control group: no diet provided, subjects eat whatever they want
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Measure changes in fasting blood lipid concentration (mg/dL) following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up. |
| 2 weeks |