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Dietary Fiber Effects on the Microbiome and Satiety (FEMS)

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ClinicalTrials.gov Identifier: NCT04611217
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Katherene Anguah, University of Missouri-Columbia

Brief Summary:
Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans.

Condition or disease Intervention/treatment Phase
Dietary Fiber Other: Dietary fiber: 10-25g Other: Dietary fiber: 5g Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Aim 1- 4-week parallel arm repeated measures Aim 2- 3 week single arm repeated measures
Masking: Single (Outcomes Assessor)
Masking Description: Aim 1- Participants are blinded to the treatment arm. The high fiber and low fiber foods are matched in palatability, appearance and energy. Laboratory staff will be blinded to the subject's diet assignment (SA1), all biochemistries, and the microbiome analysis (samples are identified by code and batch processed, all baseline and follow-up samples analyzed simultaneously).
Primary Purpose: Prevention
Official Title: Mechanisms Linking Dietary Fiber, the Microbiome and Satiety
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: High Fiber diet
Group receiving a high fiber diet
Other: Dietary fiber: 10-25g
10-25 g/day of fiber

Low Fiber diet
Control group receiving a low fiber diet
Other: Dietary fiber: 5g
5 g/day of fiber




Primary Outcome Measures :
  1. Change in microbiome composition and diversity [ Time Frame: Aim 1: On day 1, on 3 separate days during the intervention and on day 28 of the high fiber or low fiber intervention; Aim 2: within 14 days of scheduled colonoscopy visit and on 7 separate days during the intervention ]
    Fecal samples are collected on different days during the intervention for microbiome analyses using 16rRNA technique

  2. Short chain fatty acid concentration in plasma [ Time Frame: At the start and the final day on the intervention for both Aims 1 and 2 ]
    Plasma SCFA are analyzed using gas chromatography/mass spectrometry (GC/MS)

  3. Short chain fatty acids enrichment [ Time Frame: On day 2 and day 21 of the high fiber intervention-only for Aim 2 ]
    Subjects are infused with stable isotopes of the short chain fatty acids, acetate, propionate, and butyrate and then isotope dilution by an unlabeled fiber fromt he diet is used to quantify the levels of acetate, propionate and butyrate in vivo


Secondary Outcome Measures :
  1. Change in blood oxygenation level dependent (BOLD) response [ Time Frame: Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention ]
    ubjects view images of food (low calorie and high calorie) and non-food while being scanned in an fMRI machine. The change in brain activation in response to the fMRI food reactivity task is measured as the BOLD response

  2. Subjective appetite [ Time Frame: Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention ]
    Subjects rate on a visual analogue scale (VAS) at 8 different time points in Aim 1 and at 12 different time points in Aim 2 during each of the two meal test visits. The VAS is a 100 mm scale to determine subjective appetite measures (hunger, fullness, desire to eat and prospective consumption).

  3. Glucose and lipids and blood pressure [ Time Frame: Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention ]
    During each of two meal test visits for Aim 1 and Aim 2, blood samples are taken at 8 different time points for Aim 1 and 12 different time points for Aim 2 for assessment of glucose response and lipids (TG) concentrations. Blood pressure measurements are taken at the beginning of each meal test day visit for both aims.

  4. Change in appetite hormones (GLP-1 and PYY) [ Time Frame: Aim 1: On day 1 and day 28 of the high fiber or low fiber intervention. Aim 2: On day 2 and day 21 of the high fiber intervention ]
    Blood is drawn at different time points in both Aims 1 and 2 during each of the two meal test visits for assessment of appetite hormone



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women (premenopausal only)
  • Age 20-55y (Aim 1); 45-55y (Aim 2)
  • BMI ≥25 or ≤35 kg/m2 (Aim 1); ≥25 or ≤40 (Aim 2)
  • Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
  • Willing to consume a research diet
  • Willing to provide blood and fecal samples
  • At least one characteristic of the metabolic syndrome (but not diabetic)

    1. A large waistline: 35 inches or more for women 40 inches or more for men 2. High triglycerides: 150 mg/dL or higher 3. Low HDLc level: <50 mg/dL for women <40 mg/dL for men 4. High blood pressure ≥130/85 mmHg 5. Fasting blood sugar ≥100 mg/dL

  • Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c <6.5%)
  • Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)

Exclusion Criteria:

  • Pregnant or lactating
  • Postmenopausal (evidence suggests an interplay between the gut microbiome)
  • BMI of <25 or >35 kg/m2 (Aim 1); <25 or >40 kg/m2 (Aim 2)
  • Use of medications that affect the gut microbiome (e.g. antibiotics)
  • Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)
  • On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns
  • Ad libitum intake of fiber above 25g/day (mean intake in the US population is 17g/day) and < 10g/d
  • Ad libitum alcohol intake of greater than 1 drink/d for women and 2 drinks/d for men
  • History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)
  • Use of tobacco products
  • Having metal or implants in the body that are not MRI compatible (Aim 1 only)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611217


Contacts
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Contact: Katherene OB Anguah, PhD (573)-882-8966 anguahk@missouri.edu

Locations
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United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65212
Contact: Katherene O Anguah, Ph.D    573-882-8966 ext 5738828966    anguahk@missouri.edu   
Contact: Katherene O Anguah    5738828966 ext 5738828966    anguahk@missouri.edu   
Principal Investigator: Katherene O Anguah, Ph.D.         
Sub-Investigator: Elizabeth J Parks, Ph.D.         
Sub-Investigator: Shawn Christ, Ph.D.         
Sponsors and Collaborators
University of Missouri-Columbia
Publications:

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Responsible Party: Katherene Anguah, Assistant Professor, Nutrition & Exercise Phys-HES, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04611217    
Other Study ID Numbers: 2025807
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherene Anguah, University of Missouri-Columbia:
dietary fiber
satiety
microbiome
short chain fatty acids
functional magnetic resonance imaging
cardiometabolic risk