Status:
COMPLETED
Variability in Microbial Response to Dietary Fiber
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Microbial Colonization
Eligibility:
All Genders
45-65 years
Phase:
NA
Brief Summary
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 ans...
Detailed Description
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....
Eligibility Criteria
Inclusion
- Intervention Arm
- 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
- A large waistline: 35 inches or more for women 40 inches or more for men
- High triglycerides: 150 mg/dL or higher
- Low HDLc level: \<50 mg/dL for women \<40 mg/dL for men
- High blood pressure ≥130/85 mmHg
- Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose \<125 mg/dL or HbA1c \<6.5%)
- 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
- Pregnant or lactating, or planning to become pregnant
- BMI of \<20.0 or \>40.0 kg/m2
- Use of tobacco products
- Uncontrolled hypertension and blood pressure ≥ 180/110
- Use of medications that affect the gut microbiome (e.g., antibiotics)
- Taking medications known to affect appetite (phentermine) or gastrointestinal function (e.g. metformin)
- On a special diet vegetarian, or other restricted dietary patterns
- Undergoing weight loss
- Ad libitum intake of fiber above 25 g/day (mean intake in the US population is 17 g/day) and also an intake of fiber \<10 g/d
- Ad libitum alcohol intake of greater than 7 drinks/week for women and 14 drinks/week for men
- History of disease (example colon cancer, etc.)
- Live more than 45 miles away from the University because participants will need to come into the Lab every 3 days or so to pick up meals.
- Control Arm Inclusion criteria
- Men and women
- Age 45-65y: the average age of people referred for a screening colonoscopy
- Scheduled for a health-screening colonoscopy
- Willing to provide fecal samples
- 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
- Pregnant or lactating, or planning to become pregnant
- Use of medications that affect the gut microbiome (e.g., antibiotics within the past 30 days)
- History of disease (example colon cancer, active GI bleeding, inflammatory bowel disease, etc.)
- Live more than 45 miles away from the University because participants will need to come into the Lab every 3 days or so to deliver fecal samples.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06023940
Start Date
May 12 2022
End Date
October 31 2023
Last Update
July 24 2024
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65212