NCT05912348 · University of New Hampshire
The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
Low physical Activity Control
Young men and women will transition into a low physically active lifestyle for 10 days.
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.
Primary outcome measures
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.
Time frame: 10 days
We will use HOMA-IR to measure changes in insulin resistance across the 4 study groups
To determine if the combined low physical activity and added carbohydrates impairs 24-hour glucose regulation compared the other study interventions.
Time frame: 10 days
Compare 24-hour glucose regulation (mmol/L) measurements across the four study groups
To determine if fat oxidation is impaired when participants reduce their physical activity levels and consume added carbohydrates compared to the three interventions
Time frame: 10 days
Compare the change in fat oxidation after the 10 day intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Durham, New Hampshire
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2024 · Source of record for eligibility and locations