Age-associated Arterial Dysfunction, Western Diet, and Aerobic Exercise: Role of the Gut Microbiome
Status unconfirmed · Not applicable
Conditions studied: Aging
In brief
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.
Key facts
- Study ID
- NCT03334201
- Run by
- University of Colorado, Boulder
- People needed
- 120
- Starts
- 2018-03-15
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2021-10-28
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
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)
Where it is running
- University of Colorado Boulder — Boulder, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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