NCT03334201

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

Status unknown NA Last updated 28 October 2021

What this trial tests

NA trial testing Western Diet in Aging in 120 participants. Status unknown.

Timeline

15 March 2018

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	University of Colorado, Boulder
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	120
Start date	15 March 2018
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Western Diet
• Non-Western Diet

Conditions studied

• Aging — all drugs for Aging →

Sponsor

University of Colorado, Boulder

Who can join

Adults 18 to 79, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut dysbiosis and age-related neurological diseases; an innovative approach for therapeutic interventions.
   Holmes A, Finger C, Morales-Scheihing D, Lee J, et al · · 2020 · cited 43× · PMID 32755639 · DOI 10.1016/j.trsl.2020.07.012
2. Promoting healthy cardiovascular aging: emerging topics.
   Clayton ZS, Craighead DH, Darvish S, Coppock M, et al · · 2022 · cited 19× · PMID 36337728 · DOI 10.20517/jca.2022.27