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

NCT03334201 | Unknown DMC

• 1 other identifier: 16-0633
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in the gut microbiome

  Sterile fecal swabs will be collected and analyzed using 16S rRNA sequencing

  7 days

• Change in endothelial function

  Brachial artery flow-mediated dilation

  7 days

• Change in arterial stiffness

  Carotid-femoral pulse wave velocity

  7 days

Study Arms (2)

Western diet first

OTHER

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

Other: Western Diet; Other: Non-Western Diet

Non-Western diet first

OTHER

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

Other: Western Diet; Other: Non-Western Diet

Interventions

Western Diet OTHER

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

Non-Western diet first; Western diet first

Non-Western Diet OTHER

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

Non-Western diet first; Western diet first

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

RECRUITING

MeSH Terms

Interventions

Diet, Western

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Douglas R Seals, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Lubieniecki, MS

CONTACT

303-735-6410; ipalab@colorado.edu

Vienna E Brunt, PhD

CONTACT

303-735-4936; vienna.brunt@colorado.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: Randomized, single-blind crossover

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 7, 2017
• Study Start: March 15, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (1)