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RecruitingNCT05912348Updated Jul 17, 2024

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

An interventional study of Low Physical Activity and Added Carbohydrate Group and Low physical Activity Control in Insulin Resistance, Impaired Glucose Tolerance and Obesity, sponsored by University of New Hampshire. Recruiting at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by University of New Hampshire · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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?
Read the 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.

02

Conditions studied

  • Insulin Resistance
  • Impaired Glucose Tolerance
  • Obesity
  • Metabolic Disturbance
03

In context

Insulin Resistance

2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.

This study's planned enrollment of 45 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of New Hampshire is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    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).

    Behavioral: Low Physical Activity and Added Carbohydrate Group

  • Placebo comparator
    Low Physical Activity Control

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

    Behavioral: Low physical Activity Control

  • No intervention
    Normal Activity Control

    Maintains normal physical activity levels and exercise training

  • Experimental
    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).

    Behavioral: High Physical Activity and Added Carbohydrate Group

Interventions

  • BehavioralLow 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.

  • BehavioralLow physical Activity Control

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

  • BehavioralHigh 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.

06

What researchers measure

Primary outcomes

  1. To determine if low physical activity alone contributes to insulin resistance in healthy, recreationally active young men and women compared to men and women that reduce their physical activity and consume added sugar-sweetened beverages.

    We will use HOMA-IR to measure changes in insulin resistance across the 4 study groups

    Time frame: 10 days

  2. To determine if the combined low physical activity and added carbohydrates impairs 24-hour glucose regulation compared the other study interventions.

    Compare 24-hour glucose regulation (mmol/L) measurements across the four study groups

    Time frame: 10 days

  3. To determine if fat oxidation is impaired when participants reduce their physical activity levels and consume added carbohydrates compared to the three interventions

    Compare the change in fat oxidation after the 10 day intervention

    Time frame: 10 days

07

Study locations

1 of 1 sites recruiting
  • University of New Hampshire Cardiometabolic Research Laboratory
    Durham, New Hampshire 03824, United States
    Recruiting
    • Michael Brian, PhD · ContactMichael.Brian@unh.edu · 603-862-1693
    • Michael Brian, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Sep 2026, 43 months after the start.

Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 43 months is above that.

Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2023
First posted
Jun 22, 2023
StartActual
Feb 8, 2023
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Jul 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05912348
Lead sponsor
University of New Hampshire
Responsible party
Michael Brian (Assistant Professor of Kinesiology, University of New Hampshire) — Principal investigator
First posted
Jun 22, 2023
Start date
Feb 8, 2023
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 17, 2024

Study contacts

Michael Brian, PhD
Contact
Michael.Brian@unh.edu
603-714-8899
Michael S Brian, PhD
principal investigator · University of New Hampshire

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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