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Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fructose and physical inactivity
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vascular Diseases focused on measuring arterial stiffness, endothelial dysfunction, fructose, physical inactivity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fructose and physical inactivity

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in Brachial artery flow mediated dilation (FMD)
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.
Change in carotid femoral pulse wave velocity (cfPWV)
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

Full Information

First Posted
December 17, 2018
Last Updated
August 16, 2022
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03785470
Brief Title
Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle
Official Title
Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
Keywords
arterial stiffness, endothelial dysfunction, fructose, physical inactivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fructose and physical inactivity
Arm Type
Experimental
Arm Description
Subjects will consume 6 cans of soda per day and restrict their physical activity.
Intervention Type
Other
Intervention Name(s)
Fructose and physical inactivity
Intervention Description
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 Outcome Measure Information:
Title
Change in Insulin-stimulated leg blood flow
Description
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).
Time Frame
this will be assessed at baseline and at the final visit (10 days)
Secondary Outcome Measure Information:
Title
Change in Brachial artery flow mediated dilation (FMD)
Description
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.
Time Frame
this will be assessed at baseline and at the final visit (10 days)
Title
Change in carotid femoral pulse wave velocity (cfPWV)
Description
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
Time Frame
this will be assessed at baseline and at the final visit (10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila Manrique Acevedo, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

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