Recruiting

Gut Microbiome

Sponsor:

University of Colorado, Boulder

Code:

NCT03334201

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Western Diet

Non-Western Diet

Study Details

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.

Conditions

Aging

Study ID

NCT03334201

Start date

Mar 15, 2018

Status verified date

Oct, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Western diet first

To receive Western diet controlled feeding first, followed by non-Western diet controlled feeding

other: Non-Western diet first

To receive non-Western diet controlled feeding first, followed by Western diet controlled feeding

Interventions

Western Diet

high fat (40%), high sugar (25%) and low fiber (15g/day)

Non-Western Diet

low fat (25%), low sugar (15%), high fiber (30g/day)

Primary outcome measure

  • Change in the gut microbiome [ Time Frame: 7 days ]
  • Change in endothelial function [ Time Frame: 7 days ]
  • Change in arterial stiffness [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Boulder

Recruiting

Boulder, Colorado, United States, 80309

Contacts

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Oct 28, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2021-10-28.