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

Sponsor
University of New Hampshire (Other)
Overall Status
Recruiting
CT.gov ID
NCT05912348
Collaborator
(none)
34
1
3
10.7
3.2

Study Details

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:

  1. Does the addition of excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance in fit young men?

  2. 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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Obesogenic Lifestyle Group
  • Behavioral: Sedentary Control
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Cross-Sectional Study DesignRandomized Cross-Sectional Study Design
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
Actual Study Start Date :
Feb 8, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Obesogenic Lifestyle Model Group

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

Behavioral: Obesogenic Lifestyle Group
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.

Placebo Comparator: Sedentary Control

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

Behavioral: Sedentary Control
Young men will transition into a sedentary lifestyle for 10 days.

No Intervention: Normal Activity Control

Maintains normal physical activity levels and exercise training

Outcome Measures

Primary Outcome Measures

  1. To determine if sedentary activity alone contributes to insulin resistance in healthy, recreationally active young men compared to an obesogenic model. [10 days]

    We will use HOMA-IR to measure changes in insulin resistance in an obesogenic model group and a sedentary control group.

  2. To determine if an obesogenic model leads to impaired 24-hour glucose regulation compared to sedentary controls. [10 days]

    Compare 24-hour glucose regulation (mmol/L) measurements between the obesogenic lifestyle model and sedentary controls.

  3. To determine if fat oxidation is impaired following an obesogenic lifestyle model [10 days]

    Compare the change in fat oxidation after the 10 day intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of New Hampshire Cardiometabolic Research Laboratory Durham New Hampshire United States 03824

Sponsors and Collaborators

  • University of New Hampshire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Brian, Assistant Professor of Kinesiology, University of New Hampshire
ClinicalTrials.gov Identifier:
NCT05912348
Other Study ID Numbers:
  • UNH-12-FY2023_85-01
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023