Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle

NCT ID: NCT03785470

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2022-08-16

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.

Conditions

Vascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fructose and physical inactivity

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

Group Type: EXPERIMENTAL

Fructose and physical inactivity

Intervention Type: 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.

Interventions

Fructose and physical inactivity

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Camila Manrique

Associate Professor, Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camila Manrique Acevedo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Other Identifiers

2012869

Identifier Type: -

Identifier Source: org_study_id