Insulin ResistanceNCT05912348
The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
A study testing Low Physical Activity and Added Carbohydrate Group and High Physical Activity and Added Carbohydrate Group in people with Insulin Resistance and Impaired Glucose Tolerance, run by University of New Hampshire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Impaired Glucose Tolerance, Obesity
- What is being tested?
- Low Physical Activity and Added Carbohydrate Group and High Physical Activity and Added Carbohydrate Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of New Hampshire Cardiometabolic Research Laboratory
Durham, New Hampshire, 03824
Michael Brian, PhD, 603-862-1693, Michael.Brian@unh.edu
Michael Brian, PhD
About this study
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:
- Does adding excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance and impaired 24hr glucose regulation in healthy men and women?
- 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?
- 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.
- Being tested
- Low Physical Activity and Added Carbohydrate Group, Low physical Activity Control, High Physical Activity and Added Carbohydrate Group
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Physical Activity and Added Carbohydrate GroupBehavioural
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 ControlBehavioural
Young men and women will transition into a low physically active lifestyle for 10 days.
High Physical Activity and Added Carbohydrate GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Physical Activity and Added Carbohydrate Group | Experimental | 10-days of low physical activity (~5,000 steps/day) while consuming added sugar-sweetened beverages (~180 g/day). Receives: Behavioral: Low Physical Activity and Added Carbohydrate Group |
| Low Physical Activity Control | Placebo comparator | 10-days of sedentary activity (~5,000 steps/day). Receives: Behavioral: Low physical Activity Control |
| Normal Activity Control | No intervention | Maintains normal physical activity levels and exercise training |
| High Physical Activity and Added Carbohydrate Group | Experimental | 10-days of high physical activity (~11,000 steps/day) while consuming added sugar-sweetened beverages (~180 g/day). Receives: Behavioral: High Physical Activity and Added Carbohydrate Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
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
Measured: 10 days
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start8 Feb 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Cross-Sectional Study Design
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Brian, University of New Hampshire
- Investigators
- Michael S Brian, PhD, Principal investigator, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912348
- Sponsor's protocol ID
- UNH-12-FY2023_85-01
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Obesogenic Lifestyle in Recreationally Active, Young Adults
- ClinicalTrials.gov ID
- NCT05912348
- Acronym / sponsor ID
- UNH-12-FY2023_85-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adding excess carbohydrates when transitioning to a sedentary lifestyle promote insulin resistance and impaired 24hr glucose regulation in healthy men and women?
- 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?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Cross-Sectional Study Design
| Arm | Type | Receives |
|---|---|---|
| Low Physical Activity and Added Carbohydrate Group | Experimental | Behavioral: Low Physical Activity and Added Carbohydrate Group10-days of low physical activity (~5,000 steps/day) while consuming added sugar-sweetened beverages (~180 g/day). |
| Low Physical Activity Control | Placebo comparator | Behavioral: Low physical Activity Control10-days of sedentary activity (~5,000 steps/day). |
| Normal Activity Control | No intervention | –Maintains normal physical activity levels and exercise training |
| High Physical Activity and Added Carbohydrate Group | Experimental | Behavioral: High Physical Activity and Added Carbohydrate Group10-days of high physical activity (~11,000 steps/day) while consuming added sugar-sweetened beverages (~180 g/day). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- Hypertension (resting or diagnosed)
- Impaired fasting blood glucose (>100mg/dL)
- Diagnosed cardiovascular disease
- Diagnosed diabetes
- Diagnosed cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Physical Activity and Added Carbohydrate GroupYoung 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. | Behavioural | Low Physical Activity and Added Carbohydrate Group |
| Low physical Activity ControlYoung men and women will transition into a low physically active lifestyle for 10 days. | Behavioural | Low Physical Activity Control |
| High Physical Activity and Added Carbohydrate GroupYoung 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. | Behavioural | High Physical Activity and Added Carbohydrate Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Brian, PhD principal investigator
University of New Hampshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Physical Activity and Added Carbohydrate Group and High Physical Activity and Added Carbohydrate Group in people with Insulin Resistance and Impaired Glucose Tolerance, run by University of New Hampshire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Brian, PhD (603-714-8899, Michael.Brian@unh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.