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

NCT ID: NCT03334201

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, single-blind crossover
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
Single-blind

Study Groups

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Western diet first

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

Group Type OTHER

Western Diet

Intervention Type OTHER

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

Non-Western Diet

Intervention Type OTHER

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

Group Type OTHER

Western Diet

Intervention Type OTHER

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

Non-Western Diet

Intervention Type OTHER

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

Interventions

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Western Diet

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

Intervention Type OTHER

Non-Western Diet

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Douglas Seals

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas R Seals, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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University of Colorado Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kara Lubieniecki, MS

Role: CONTACT

Phone: 303-735-6410

Email: [email protected]

Vienna E Brunt, PhD

Role: CONTACT

Phone: 303-735-4936

Email: [email protected]

Facility Contacts

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Kara Lubieniecki, MS

Role: primary

Vienna E Brunt, PhD

Role: backup

Other Identifiers

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16-0633

Identifier Type: -

Identifier Source: org_study_id