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Age-associated Arterial Dysfunction, Western Diet, and Aerobic Exercise: Role of the Gut Microbiome

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ClinicalTrials.gov Identifier: NCT03334201
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder

Brief Summary:
The risk of developing cardiovascular diseases increases with aging largely due to age-related declines in the function of arteries (arterial dysfunction), which are influenced by common lifestyle factors such as consumption of a "Western" diet and lack of sufficient physical activity; thus, it is important to study how these factors interact to affect artery function. This study will determine whether changes to the gut microbiome (the collection of bacteria and other "microbes" living in the intestinal tract) with aging, Western diet consumption and aerobic exercise influence arterial function, and the biological pathways (mechanisms) involved. Specifically, the investigators will perform a randomized, single-blind, controlled feeding crossover study design (comparing Western diet to non-Western diet consumption) in young and older, exercising and non-exercising healthy adults to determine the time course effects (temporal association) of diet on the gut microbiome and arterial function. Overall, this research has potential to establish the gut microbiome as a possible target for treating/preventing age-related arterial dysfunction and reducing the risk of age-associated cardiovascular diseases.

Condition or disease Intervention/treatment Phase
Aging Other: Western Diet Other: Non-Western Diet Not Applicable

Detailed Description:
In order to investigate how age-related changes to the gut microbiome, as modulated by Western diet and exercise, influences arterial function in humans, the investigators will capitalize on the plasticity of the gut microbiome to dietary perturbations. A randomized, single-blind, 2x1-week dietary intervention crossover study (with 3 week washout) will be conducted in young (18-29 years) and old (60-79 years), exercising and non-exercising, male and female adults from all races and ethnic backgrounds. Testing will take place on the University of Colorado Boulder main campus at the Clinical and Translational Research Center (CTRC - located in the Wardenburg Health Center). Subjects will undergo telephone and in-person CTRC screening, with those eligible assigned to either Group A or Group B using block randomization stratified by age and exercise status. Group A will undergo isocaloric WD feeding (high fat [40%], high sugar [25%], low fiber [15g], low nutrient) during Phase 1 (first 1-week treatment period) and non-WD feeding (low-fat [25%], low sugar [15%], high fiber [22g], high nutrient) during Phase 2 (second 1-week treatment period). Group B will undergo the dietary interventions in the opposite order. Phases 1 and 2 will be separated by a 3-week washout period to prevent carry over effects. During each 1-week intervention period, fecal swabs will be collected daily to characterize the gut microbiome and vascular function, will be measured at baseline and after 2 and 7 days of controlled feeding to gain insight into the temporal relation between these outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, single-blind crossover
Masking: Single (Investigator)
Masking Description: Single-blind
Primary Purpose: Basic Science
Official Title: Age-associated Arterial Dysfunction, Western Diet, and Aerobic Exercise: Role of the Gut Microbiome
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Western diet first
To receive Western diet controlled feeding first, followed by non-Western diet controlled feeding
Other: Western Diet
high fat (40%), high sugar (25%) and low fiber (15g/day)

Other: Non-Western Diet
low fat (25%), low sugar (15%), high fiber (30g/day)

Non-Western diet first
To receive non-Western diet controlled feeding first, followed by Western diet controlled feeding
Other: Western Diet
high fat (40%), high sugar (25%) and low fiber (15g/day)

Other: Non-Western Diet
low fat (25%), low sugar (15%), high fiber (30g/day)




Primary Outcome Measures :
  1. Change in the gut microbiome [ Time Frame: 7 days ]
    Sterile fecal swabs will be collected and analyzed using 16S rRNA sequencing

  2. Change in endothelial function [ Time Frame: 7 days ]
    Brachial artery flow-mediated dilation

  3. Change in arterial stiffness [ Time Frame: 7 days ]
    Carotid-femoral pulse wave velocity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-29 or 60-79 years
  • Participating in < 30 min aerobic exercise < 2x/wk for >3 years OR > 45 min vigorous aerobic exercise > 4x/wk for > 3 yrs
  • Currently consuming levels of dietary fat intake with the 40th-60th percentile of Americans based on the NHANES survey (29-37% calories from fat)
  • Healthy (no clinical disease)
  • Body mass index < 30 kg/m2
  • Ankle-brachial blood pressure index > 0.9
  • Total cholesterol < 240 mg/dl
  • Fasting plasma glucose < 110 mg/dl
  • Weight stable in the past 6 months

Exclusion Criteria:

  • Current or past (within 3 months of screening) use of dietary supplements, anti-inflammatory medications, drugs known to affect the gut microbiome (antibiotics, pre/probiotics, antifungals, antivirals, antiparasitics), or gastrointestinal-targeted drugs (proton pump inhibitors, H2 receptor antagonists, laxatives, antidiarrheal medications)
  • Current of past (within 5 years) smoking
  • Major change in health status in the last 6 months
  • Chronic clinical diseases (e.g., inflammatory bowl diseases, cardiovascular disease, diabetes, neurological disorders, dementia or other brain diseases of aging)

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): NCT03334201


Contacts
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Contact: Kara Lubieniecki, MS 303-735-6410 ipalab@colorado.edu
Contact: Vienna E Brunt, PhD 303-735-4936 vienna.brunt@colorado.edu

Locations
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United States, Colorado
University of Colorado Boulder Recruiting
Boulder, Colorado, United States, 80309
Contact: Kara Lubieniecki, MS    303-735-6410    ipalab@colorado.edu   
Contact: Vienna E Brunt, PhD    303-735-4936    vienna.brunt@colorado.edu   
Sponsors and Collaborators
University of Colorado, Boulder
University of California, San Diego
Investigators
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Principal Investigator: Douglas R Seals, PhD University of Colorado, Boulder
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Responsible Party: Douglas Seals, Distinguished Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03334201    
Other Study ID Numbers: 16-0633
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No