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Completed

NCT Number: NCT03785470

Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

The purpose of this study is to determine if short-term adoption of a Westernized lifestyle characterized by physical inactivity and increased consumption of fructose will result in metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption. Augmented fructose consumption will be achieved via commercially available soda beverages which are high in fructose. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

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Key information

Conditions

Vascular Diseases Behavior Cardiovascular Diseases Sedentary Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

Men and women who regularly engage in >10,000 steps per day, age 18-45 years, body mass index < 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are eligible will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer to quantify if individuals achieve <5000 steps/day. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women who regularly engage in >10,000 steps per day
  • Age 18-45 years
  • Body mass index < 30 kg/m2
  • No history of chronic disease

Exclusion criteria

  • Known cardiovascular disease including hypertension, heart failure, coronary artery disease, and stroke
  • Renal or hepatic diseases
  • Active cancer
  • Autoimmune diseases
  • Current use of immunosuppressant therapy
  • Excessive alcohol consumption (> 14 drinks/week for men and >7 drinks/week for women)
  • Current tobacco use
  • Current pregnancy
  • Diagnosis of type 2 diabetes
  • Regular consumption of >2 non-diet sodas/day

Treatment and study plan

Fructose and physical inactivity

Other

Subjects will drink 6 cans of regular sodas daily (divided throughout the day) and will decreased physical activity to less than 5000 steps daily for 10 days.

Primary outcomes

  1. Change in Insulin-stimulated leg blood flow

    Time frame: this will be assessed at baseline and at the final visit (10 days)

    Subjects will be instrumented with EKG for contrast-enhanced ultrasound (CEU) measurements. We will perform a hyperinsulinemic euglycemic clamp to evaluate microvascular perfusion of skeletal muscle via CEU. Insulin will be infused at a constant rate to mimic postprandial insulin concentrations and glucose maintained at fasting values via a variable 20% dextrose infusion. At baseline and in the steady state phase of the insulin clamp, we will assess microvascular perfusion in the vastus lateralis muscle using CEU (IE-33, Philips Ultrasound), via infusion of perflutren lipid microspheres. Microvascular perfusion will be assessed as an A-value. A is the video intensity plateau after complete replenishment reflecting relative microvascular blood volume (MBV).

Secondary outcomes

  1. Change in Brachial artery flow mediated dilation (FMD)

    Time frame: this will be assessed at baseline and at the final visit (10 days)

    Brachial artery FMD will be assessed at baseline and at 10 days. FMD is a measurement of conduit artery endothelial function. FMD is assessed immediately after each PWV measurement. Shear rate AUC until peak diameter is calculated as stimulus for FMD and used in covariate analysis. All measurements will be performed by the same technician.

  2. Change in carotid femoral pulse wave velocity (cfPWV)

    Time frame: this will be assessed at baseline and at the final visit (10 days)

    It is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same technician

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 24, 2018
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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