Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

NCT03785470 | Completed DMC

• 1 other identifier: 2012869
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Diseases

Keywords

arterial stiffness; endothelial dysfunction; fructose; physical inactivity

Outcome Measures

Primary Outcomes (1)

• Change in Insulin-stimulated leg blood flow

  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).

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

Secondary Outcomes (2)

• Change in Brachial artery flow mediated dilation (FMD)

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

• Change in carotid femoral pulse wave velocity (cfPWV)

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

Study Arms (1)

Fructose and physical inactivity

EXPERIMENTAL

Subjects will consume 6 cans of soda per day and restrict their physical activity.

Other: Fructose and physical inactivity

Interventions

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.

Fructose and physical inactivity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Sedentary Behavior

Interventions

Fructose

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Camila Manrique Acevedo, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: November 30, 2018
• Primary Completion: August 1, 2022
• Study Completion: August 16, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)