The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults

NCT ID: NCT05912348

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2026-09-30

Brief Summary

This clinical trial aims to learn about the alterations in insulin resistance and metabolic flexibility following a transition to an obesogenic lifestyle in fit young men and women. The main questions it aims to answer are:

1. Does adding excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance and impaired 24hr glucose regulation in healthy men and women?

2. Does adding excess carbohydrates when transitioning to a sedentary lifestyle lower the body's ability to break down fats and carbohydrates in healthy men and women?

3. Does the added physical activity blunt shifts in carbohydrate and fat oxidation in healthy men and women?

Detailed Description

Excess adiposity remains a critical health issue in the United States. Obesity and severe obesity are projected to reach approximately 34% and 9% by 2030, respectively. However, recent 2021 NHANES data reveals that our obesity and severe obesity population has already surpassed these estimates reaching 41.9% and 9.2% by 2022, respectively. While early childhood obesity has a prevalence of about 22%, which can lead to obesity during adulthood, young adulthood (20-39 years old) is another critical time where young adults without obesity or severe obesity will accumulate excess adiposity as part of this transition into middle-aged adulthood (40-59 years). In particular, young adults often transition from higher levels of physical activity (i.e., sports participation in high school, increased walking to class on college campuses, increased free time for physical activity) to lower levels of physical activity (e.g., full-time employment) and limited time to prepare healthy meals. Although obesity models tend to be complex, with multiple contributors to the development of obesity, easily accessible and rapidly digestible carbohydrates with high glycemic indexes have contributed significantly to the rise in obesity and cardiometabolic diseases in the United States.

Previous animal models have demonstrated that high carbohydrate or high-fat diets and increased sedentary activity lead to excess adiposity and insulin resistance in animal models. Animal models help us to examine mechanistic contributors to obesity and adverse cardiometabolic risks. A recently developed obesogenic lifestyle model provides an excellent model for studying the transition to an obesogenic lifestyle in healthy young adults. The obesogenic lifestyle model uses an acute exposure to a sedentary lifestyle (~5,000 steps/day) and increased carbohydrate intake (~2 liters of soda/day) for a 10-day period. Using this obesogenic lifestyle model, researchers found that the acute obesogenic lifestyle model increased insulin resistance (measured by HOMA-IR) in both men and women, but only men had declines in vascular insulin sensitivity. The reduction in vascular sensitivity is considered an early precursor for the development of metabolic dysregulation and cardiovascular disease. Nonetheless, it remains unclear whether insulin resistance and vascular insulin sensitivity were due to a lack of physical activity or increased carbohydrate intake. Further, the model must be independently validated to confirm its ability to induce insulin resistance to create a sustainable model for repeated studies.

From a behavioral aspect, the designed obesogenic lifestyle model provides an opportunity to study increases in insulin resistance when individuals transition during young adulthood into a lifestyle that induces barriers to maintaining physical activity and impairs diet quality. Importantly, this young adult population remains underrepresented in the literature compared to studies on obese or physically inactive adults. Therefore, the model has ecological relevance. The model also provides an opportunity for earlier interventions to be developed to mitigate the harmful consequences that may be offset with simple interventions that promote physical activity. Therefore, the global hypothesis of this research study is that the obesogenic lifestyle model will be a suitable model for studying the early onset of insulin resistance as it will increase insulin resistance (HOMA-IR) and impair glucose regulation in recreationally active young men and women.

Conditions

Insulin Resistance; Impaired Glucose Tolerance; Obesity; Metabolic Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low Physical Activity and Added Carbohydrate Group

10-days of low physical activity (\~5,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Group Type: EXPERIMENTAL

Low Physical Activity and Added Carbohydrate Group

Intervention Type: BEHAVIORAL

Young men and women will transition into a low physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group. One of the control groups will undergo a low physical activity intervention.

Low Physical Activity Control

10-days of sedentary activity (\~5,000 steps/day).

Group Type: PLACEBO_COMPARATOR

Low physical Activity Control

Intervention Type: BEHAVIORAL

Young men and women will transition into a low physically active lifestyle for 10 days.

Normal Activity Control

Maintains normal physical activity levels and exercise training

Group Type: NO_INTERVENTION

No interventions assigned to this group

High Physical Activity and Added Carbohydrate Group

10-days of high physical activity (\~11,000 steps/day) while consuming added sugar-sweetened beverages (\~180 g/day).

Group Type: EXPERIMENTAL

High Physical Activity and Added Carbohydrate Group

Intervention Type: BEHAVIORAL

Young men and women will transition into a high physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group.

Interventions

Low Physical Activity and Added Carbohydrate Group

Young men and women will transition into a low physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group. One of the control groups will undergo a low physical activity intervention.

Intervention Type: BEHAVIORAL

Low physical Activity Control

Young men and women will transition into a low physically active lifestyle for 10 days.

Intervention Type: BEHAVIORAL

High Physical Activity and Added Carbohydrate Group

Young men and women will transition into a high physically active lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups and one experimental group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-30 years of age
• Recreationally active completing 75-150 minutes of moderate-to-vigorous intensity exercise (>2 days/week).
• Fair cardiorespiratory fitness levels (Men: VO2>38.4 ml/kg/min; Women: VO2>32.6 ml/kg/min).

Exclusion Criteria

• Hypertension (resting or diagnosed)
• Impaired fasting blood glucose (>100mg/dL)
• Diagnosed cardiovascular disease
• Diagnosed diabetes
• Diagnosed cancer
• Diagnosed chronic kidney disease
• Diagnosed musculoskeletal disorders that prevents the individual from exercising on a bike.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Hampshire

OTHER

Sponsor Role: lead

Responsible Party

Michael Brian

Assistant Professor of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael S Brian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Hampshire

Locations

University of New Hampshire Cardiometabolic Research Laboratory

Durham, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Brian, PhD

Role: CONTACT

Michael.Brian@unh.edu

603-714-8899

Facility Contacts

Michael Brian, PhD

Role: primary

Michael.Brian@unh.edu

603-862-1693

Other Identifiers

UNH-12-FY2023_85-01

Identifier Type: -

Identifier Source: org_study_id