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

Primary Purpose

Insulin Resistance, Impaired Glucose Tolerance, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obesogenic Lifestyle Group
Sedentary Control
Sponsored by
University of New Hampshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

18 Years - 26 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Young men (18-26) Recreationally active completing 75-150 minutes of moderate-to-vigorous intensity exercise (>2 days/week). Fair cardiorespiratory fitness levels (VO2>38.6 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.

Sites / Locations

  • University of New Hampshire Cardiometabolic Research LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Obesogenic Lifestyle Model Group

Sedentary Control

Normal Activity Control

Arm Description

10-days of sedentary activity (~5,000 steps/day) while consuming added sugar-sweetened beverages (250g/day).

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

Maintains normal physical activity levels and exercise training

Outcomes

Primary Outcome Measures

To determine if sedentary activity alone contributes to insulin resistance in healthy, recreationally active young men compared to an obesogenic model.
We will use HOMA-IR to measure changes in insulin resistance in an obesogenic model group and a sedentary control group.
To determine if an obesogenic model leads to impaired 24-hour glucose regulation compared to sedentary controls.
Compare 24-hour glucose regulation (mmol/L) measurements between the obesogenic lifestyle model and sedentary controls.
To determine if fat oxidation is impaired following an obesogenic lifestyle model
Compare the change in fat oxidation after the 10 day intervention

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
June 12, 2023
Sponsor
University of New Hampshire
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1. Study Identification

Unique Protocol Identification Number
NCT05912348
Brief Title
The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
Official Title
The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Hampshire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to learn about the alterations insulin resistance and metabolic flexibility following a transition to an obesogenic lifestyle in fit young men. The main questions it aims to answer are: Does the addition of excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance in fit young men? Does the addition of excess carbohydrates when transitioning to a sedentary lifestyle lower the body's ability to break down fats and carbohydrates in fit young men?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Impaired Glucose Tolerance, Obesity, Metabolic Disturbance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Cross-Sectional Study Design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obesogenic Lifestyle Model Group
Arm Type
Experimental
Arm Description
10-days of sedentary activity (~5,000 steps/day) while consuming added sugar-sweetened beverages (250g/day).
Arm Title
Sedentary Control
Arm Type
Placebo Comparator
Arm Description
10-days of sedentary activity (~5,000 steps/day).
Arm Title
Normal Activity Control
Arm Type
No Intervention
Arm Description
Maintains normal physical activity levels and exercise training
Intervention Type
Behavioral
Intervention Name(s)
Obesogenic Lifestyle Group
Intervention Description
Young men will transition into a sedentary lifestyle for 10 days and consume added sugar-sweetened beverages. The intervention group will be compared to two control groups. One of the control groups will undergo a sedentary intervention.
Intervention Type
Behavioral
Intervention Name(s)
Sedentary Control
Intervention Description
Young men will transition into a sedentary lifestyle for 10 days.
Primary Outcome Measure Information:
Title
To determine if sedentary activity alone contributes to insulin resistance in healthy, recreationally active young men compared to an obesogenic model.
Description
We will use HOMA-IR to measure changes in insulin resistance in an obesogenic model group and a sedentary control group.
Time Frame
10 days
Title
To determine if an obesogenic model leads to impaired 24-hour glucose regulation compared to sedentary controls.
Description
Compare 24-hour glucose regulation (mmol/L) measurements between the obesogenic lifestyle model and sedentary controls.
Time Frame
10 days
Title
To determine if fat oxidation is impaired following an obesogenic lifestyle model
Description
Compare the change in fat oxidation after the 10 day intervention
Time Frame
10 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Young men (18-26) Recreationally active completing 75-150 minutes of moderate-to-vigorous intensity exercise (>2 days/week). Fair cardiorespiratory fitness levels (VO2>38.6 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Brian, PhD
Phone
603-714-8899
Email
Michael.Brian@unh.edu
Facility Information:
Facility Name
University of New Hampshire Cardiometabolic Research Laboratory
City
Durham
State/Province
New Hampshire
ZIP/Postal Code
03824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Brian, PhD
Phone
603-862-1693
Email
Michael.Brian@unh.edu
First Name & Middle Initial & Last Name & Degree
Michael Brian, PhD

12. IPD Sharing Statement

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

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