ObesityARrOWNCT03857048
Adaptive Responses to Overfeeding and Weight
A study testing Weight Loss, Exercise training and Overfeeding in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To more effectively address the problem of weight regain following weight loss for obese individuals, this study will evaluate the underlying biology of the reduced obese state. In depth studies of appetite, energy expenditure, physical activity levels and fat metabolism will be completed in obese and reduced obese… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight Loss, Exercise training and Overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 1 Jan 2024
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 30-38 kg/m2 and weight stable over the previous 6 months.
- Satisfied with current weight and not planning to lose weight at the time of enrollment (persons with obesity control group) -or- not satisfied with current weight and motivated to lose weight at the time of enrollment (reduced obese groups)
- No more than 90 min or 3 bouts of planned physical activity/wk.
- Pass a medical and physical screening performed by the study physician.
- Reporting a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100 h and getting up between 0600 and 0900 h with >7 h and <9.25 h in bed.
- Live or work within 45 minutes of the CU-AMC (reduced obese groups only) (exceptions may be made at the discretion of the Study PI on a case by case basis for highly motivated subjects).
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- Own a smartphone (Android or Apple iOS).
- For Females
- Not currently pregnant or lactating
- Not pregnant within the past 6 months
- Not planning to become pregnant in the next 12 months; sexually active women of childbearing potential may be enrolled if they use a reliable means of contraception
- Capable and willing to provide informed consent, understand exclusion criteria, and accept the randomized group assignment (reduced obese groups)
Who cannot join
- Being considered unsafe to participate as determined by the study physician;
- Taking medications affecting weight, triglycerides, or energy intake/energy expenditure in the last 3 months;
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- Score > 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
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- Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of >10 on the Epworth sleepiness scale or >5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
- Being positive for human immunodeficiency virus or hepatitis B or C;
- History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve);
- Being a smoker or having been a smoker in the previous 6 months;
- Abnormal eating patterns identified by registered dietitian interview (dietary fat<15%, dietary fat>45%, dietary protein >30%);
- Working night shifts;
- Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
- Traveling > 2 time zones 2 weeks prior to an inpatient CTRC study visit;
- Currently participating in any formal weight loss or physical activity programs or clinical trials.
Trial locations and contacts
1 site in 1 country.
Emilee Mickaliger, BS contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Adaptive Responses to Overfeeding and Weight Regain in Reduced Obese Individuals
To more effectively address the problem of weight regain following weight loss for obese individuals, this study will evaluate the underlying biology of the reduced obese state. In depth studies of appetite, energy expenditure, physical activity levels and fat metabolism will be completed in obese and reduced obese individuals; with the latter subdivided into those who have lost weight with diet alone or diet plus exercise. Individuals will be studied following a brief overfeeding period to better understand how differences in biological responses to overeating might be involved in promoting or protecting against weight gain.
Read the detailed description
The persistent problem of weight regain following weight loss is perhaps the most significant barrier to addressing the current obesity epidemic. The biological drive to regain weight following weight loss is due in part to increased appetite leading to increased energy intake (EI) and reductions in energy expenditure (EE) in part due to changes in energy expended in physical activity (PA). These physiological adaptations to weight loss are most relevant during episodes of dietary indiscretion resulting in overfeeding (OF) when reduced obese (RO) people fail to respond to the state of positive energy balance in a way that maintains the reduced state. There is increasing evidence that RO individuals who exercise (RO-Ex) are less like to regain as compared to RO individuals who are sedentary (RO-Sed). Previous studies were conducted on the effects of OF on EI, EE, PA and fat metabolism in non-obese individuals either prone (OP) or resistant to obesity (OR). Subjects were then followed for 5 years to measure weight change. These studies showed that differences in the response of nocturnal fat oxidation and higher levels of moderate/vigorous PA following OF correlated with 5 year weight gain suggesting that these factors were potentially important mechanisms for weight gain. Previous work has shown that measures of hunger fail to suppress with OF in RO individuals and that nocturnal fat oxidation is reduced in RO-Sed but maintained in RO-Ex following a day that included a bout of exercise. This study will look at the responses of EE, EI, PA and fat metabolism to OF (40% above basal energy for 3 days) in obese, RO-Sed and RO-Ex men and women and correlate these responses to weight change over the subsequent year. The hypothesis is that changes in the response of one or more of these variables to OF will correlate with weight regain. The Significance of the studies lies in the fact that subjects will begin to clarify the metabolic mechanisms that underlie a propensity for weight regain in RO individuals. Innovation: The proposed studies will systematically examine a range of responses to OF and prospectively correlate them with weight gain while taking into account aspects of behavior relevant to weight regain. The hope is that these studies will lay a foundation for future studies that will examine the mechanisms underlying specific adaptive responses that directly relate to weight regain and help with the design of strategies to address and/or respond to these processes.
- Conditions
- Obesity
- Being tested
- Weight Loss, Exercise training, Overfeeding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossOther
12-wk weight loss intervention using a meal replacement strategy (Health \& Nutrition Technology, Carmel, CA), with an 8-10% weight loss goal
Exercise trainingOther
16-wk supervised endurance exercise training program
OverfeedingOther
3-day hypercaloric diet designed to overfeed by 40% above total daily energy requirements
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Persons with obesity who do not undergo weight loss will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. Receives: Other: Overfeeding |
| Reduced obese + diet + exercise | Experimental | Persons with obesity randomized to a weight loss program consisting of caloric restriction, behavioral support, and supervised endurance exercise training. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. Receives: Other: Weight Loss; Other: Exercise training; Other: Overfeeding |
| Reduced obese + diet group | Active comparator | Persons with obesity randomized to a weight loss program consisting of caloric restriction and behavioral support. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. Receives: Other: Weight Loss; Other: Overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat oxidation as a correlate of weight regain as measured by room calorimetry
Fat oxidation as a correlate of weight regain will be assessed in both reduced obese groups with room calorimetry on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 24 hour period on day 7 of two diet conditions - one overfed & one eucaloric condition; weeks 16 & 20
Secondary outcomes (16)
Body weight per scale
Body weight will be measured via clinic scale. Change in body weight in response to the weight loss intervention
Measured: Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
Body Composition via DXA
Body composition will be measured via DXA, Change in body composition in response to the weight loss intervention
Measured: Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
Change in substrate utilization as measured by room calorimetry
Substrate utilization will be measured by room calorimetry (change = overfeeding diet condition - eucaloric diet condition)
Measured: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and week 16 & 20 for reduced groups
Change in nocturnal lipolysis as measured by use of stable isotope tracer
Lipolysis will be measured using stable isotope tracers (change = overfeeding diet condition - eucaloric diet condition)
Measured: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in total energy expenditure (TEE) as measured by room calorimetry
TEE will be measured by room calorimetry (change = overfeeding diet condition - eucaloric diet condition)
Measured: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in spontaneous physical activity (SPA) as measured by accelerometers
SPA will be measured using accelerometers (change = overfeeding diet condition - eucaloric diet condition)
Measured: 7 days, on days 4-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in spontaneous food intake measured with an ad libitum diet
Spontaneous food intake will be measured during a 3 day ad libitum diet (change = overfeeding diet condition - eucaloric diet condition)
Measured: 3 days - on days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in hunger and satiety using Visual Analog Scale
Hunger and satiety will be measured using visual analog scales (change = overfeeding diet condition - eucaloric diet condition)
Measured: 3 days - on days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in 24h hormone and metabolite profiles as measured by assay of plasma samples
24h hormone and metabolite profiles will be assayed in plasma samples obtained during inpatient study visits (change = overfeeding diet condition - eucaloric diet condition)
Measured: 3 days - days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Lipolysis as a correlate of weight regain as measured by stable isotope tracer
Lipolysis as a correlate of weight regain will be assessed in both reduced obese groups with a stable isotope tracer on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Total energy expenditure (TEE) as a correlate of weight regain as measured by room calorimetry
TEE as a correlate of weight regain will be assessed in both reduced obese groups with room calorimetry on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Spontaneous physical activity (SPA) as a correlate of weight regain as measured by accelerometers
SPA as a correlate of weight regain will be assessed in both reduced obese groups with accelerometers on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 7 days, on days 4-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Spontaneous food intake as a correlate of weight regain as measured with an ad libitum diet
SPA as a correlate of weight regain will be assessed in both reduced obese groups with an ad libitum diet on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 3 days - days 8-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
24h hormone and metabolite profiles as a correlate of weight regain as measured by assay of plasma samples
24h hormone and metabolite profiles as a correlate of weight regain will be assessed in both reduced obese groups by assay of plasma samples on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
Measured: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Total daily energy expenditure as a correlate of weight regain as measured by doubly labeled water
Total daily energy expenditure as a correlate of weight regain will be measured in both reduced obese groups using doubly labeled water after the second diet condition intervention
Measured: two 1 week periods at 1 month and 1 year after second diet condition; week 8 and week 56 for controls and week 24 and week 72 for reduced
Correlates of Weight Regain as measured by questionnaire
Correlates of weight regain will be assessed in both reduced obese groups with questionnaires periodically over the intervention and follow-up period
Measured: 30 minutes at baseline and every 8 weeks for 1 year following second diet condition; weeks 12, 20, 28, 36, 44, 52 for controls and weeks 28, 36, 44, 52, 60, 68, for reduced.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start15 Feb 2019
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Persons with obesity will be randomized to receive weight loss with or without supervised exercise. Metabolic phenotyping studies will be performed in both groups in the weight reduced state and compared to a group of obese persons not undergoing weight loss. All participants will be followed for a period of 1 year following metabolic phenotyping to track longitudinal changes in weight and other relevant outcomes measures.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Sponsor
- Investigators
- Daniel Bessesen, MD, Principal investigator, University of Colorado Anschutz Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857048
- Sponsor's protocol ID
- 18-0091
- Acronym
- ARrOW
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2018
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Responses to Overfeeding and Weight Regain in Reduced Obese Individuals
- ClinicalTrials.gov ID
- NCT03857048
- Acronym / sponsor ID
- ARrOW / 18-0091
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 27 Feb 2019 (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.
To more effectively address the problem of weight regain following weight loss for obese individuals, this study will evaluate the underlying biology of the reduced obese state. In depth studies of appetite, energy expenditure, physical activity levels and fat metabolism will be completed in obese and reduced obese individuals; with the latter subdivided into those who have lost weight with diet alone or diet plus exercise. Individuals will be studied following a brief overfeeding period to better understand how differences in biological responses to overeating might be involved in promoting or protecting against weight gain.
Detailed description
The persistent problem of weight regain following weight loss is perhaps the most significant barrier to addressing the current obesity epidemic. The biological drive to regain weight following weight loss is due in part to increased appetite leading to increased energy intake (EI) and reductions in energy expenditure (EE) in part due to changes in energy expended in physical activity (PA). These physiological adaptations to weight loss are most relevant during episodes of dietary indiscretion resulting in overfeeding (OF) when reduced obese (RO) people fail to respond to the state of positive energy balance in a way that maintains the reduced state. There is increasing evidence that RO individuals who exercise (RO-Ex) are less like to regain as compared to RO individuals who are sedentary (RO-Sed). Previous studies were conducted on the effects of OF on EI, EE, PA and fat metabolism in non-obese individuals either prone (OP) or resistant to obesity (OR). Subjects were then followed for 5 years to measure weight change. These studies showed that differences in the response of nocturnal fat oxidation and higher levels of moderate/vigorous PA following OF correlated with 5 year weight gain suggesting that these factors were potentially important mechanisms for weight gain. Previous work has shown that measures of hunger fail to suppress with OF in RO individuals and that nocturnal fat oxidation is reduced in RO-Sed but maintained in RO-Ex following a day that included a bout of exercise. This study will look at the responses of EE, EI, PA and fat metabolism to OF (40% above basal energy for 3 days) in obese, RO-Sed and RO-Ex men and women and correlate these responses to weight change over the subsequent year. The hypothesis is that changes in the response of one or more of these variables to OF will correlate with weight regain. The Significance of the studies lies in the fact that subjects will begin to clarify the metabolic mechanisms that underlie a propensity for weight regain in RO individuals. Innovation: The proposed studies will systematically examine a range of responses to OF and prospectively correlate them with weight gain while taking into account aspects of behavior relevant to weight regain. The hope is that these studies will lay a foundation for future studies that will examine the mechanisms underlying specific adaptive responses that directly relate to weight regain and help with the design of strategies to address and/or respond to these processes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Persons with obesity will be randomized to receive weight loss with or without supervised exercise. Metabolic phenotyping studies will be performed in both groups in the weight reduced state and compared to a group of obese persons not undergoing weight loss. All participants will be followed for a period of 1 year following metabolic phenotyping to track longitudinal changes in weight and other relevant outcomes measures.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: OverfeedingPersons with obesity who do not undergo weight loss will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. |
| Reduced obese + diet + exercise | Experimental | Other: Weight Loss, Other: Exercise training, Other: OverfeedingPersons with obesity randomized to a weight loss program consisting of caloric restriction, behavioral support, and supervised endurance exercise training. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. |
| Reduced obese + diet group | Active comparator | Other: Weight Loss, Other: OverfeedingPersons with obesity randomized to a weight loss program consisting of caloric restriction and behavioral support. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- BMI of 30-38 kg/m2 and weight stable over the previous 6 months.
- Satisfied with current weight and not planning to lose weight at the time of enrollment (persons with obesity control group) -or- not satisfied with current weight and motivated to lose weight at the time of enrollment (reduced obese groups)
- No more than 90 min or 3 bouts of planned physical activity/wk.
- Pass a medical and physical screening performed by the study physician.
- Reporting a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100 h and getting up between 0600 and 0900 h with >7 h and <9.25 h in bed.
Key exclusion criteria (15 listed)
- Being considered unsafe to participate as determined by the study physician;
- Taking medications affecting weight, triglycerides, or energy intake/energy expenditure in the last 3 months;
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
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 |
|---|---|---|
| Weight Loss12-wk weight loss intervention using a meal replacement strategy (Health \& Nutrition Technology, Carmel, CA), with an 8-10% weight loss goal | Other | Reduced obese + diet + exercise, Reduced obese + diet group |
| Exercise training16-wk supervised endurance exercise training program | Other | Reduced obese + diet + exercise |
| Overfeeding3-day hypercaloric diet designed to overfeed by 40% above total daily energy requirements | Other | Control, Reduced obese + diet + exercise, Reduced obese + diet group |
Primary outcome
Fat oxidation as a correlate of weight regain as measured by room calorimetry
Time frame: 24 hour period on day 7 of two diet conditions - one overfed & one eucaloric condition; weeks 16 & 20
Fat oxidation as a correlate of weight regain will be assessed in both reduced obese groups with room calorimetry on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.
16 secondary outcomes
Body weight per scale
Time frame: Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
Body Composition via DXA
Time frame: Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
Change in substrate utilization as measured by room calorimetry
Time frame: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and week 16 & 20 for reduced groups
Change in nocturnal lipolysis as measured by use of stable isotope tracer
Time frame: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in total energy expenditure (TEE) as measured by room calorimetry
Time frame: 24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in spontaneous physical activity (SPA) as measured by accelerometers
Time frame: 7 days, on days 4-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in spontaneous food intake measured with an ad libitum diet
Time frame: 3 days - on days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in hunger and satiety using Visual Analog Scale
Time frame: 3 days - on days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Change in 24h hormone and metabolite profiles as measured by assay of plasma samples
Time frame: 3 days - days 8-10 - of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Lipolysis as a correlate of weight regain as measured by stable isotope tracer
Time frame: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Total energy expenditure (TEE) as a correlate of weight regain as measured by room calorimetry
Time frame: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Spontaneous physical activity (SPA) as a correlate of weight regain as measured by accelerometers
Time frame: 7 days, on days 4-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Spontaneous food intake as a correlate of weight regain as measured with an ad libitum diet
Time frame: 3 days - days 8-10 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
24h hormone and metabolite profiles as a correlate of weight regain as measured by assay of plasma samples
Time frame: 24 period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced
Total daily energy expenditure as a correlate of weight regain as measured by doubly labeled water
Time frame: two 1 week periods at 1 month and 1 year after second diet condition; week 8 and week 56 for controls and week 24 and week 72 for reduced
Correlates of Weight Regain as measured by questionnaire
Time frame: 30 minutes at baseline and every 8 weeks for 1 year following second diet condition; weeks 12, 20, 28, 36, 44, 52 for controls and weeks 28, 36, 44, 52, 60, 68, for reduced.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Emilee Mickaliger, BS contact
Daniel Bessesen, MD principal investigator
University of Colorado Anschutz Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss, Exercise training and Overfeeding in people with Obesity, run by University of Colorado, Denver 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 12 inclusion and 15 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 7 Apr 2023. 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. 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 Sheila Steinke, MS (303.724.3304, sheila.steinke@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat oxidation as a correlate of weight regain as measured by room calorimetry (time frame: 24 hour period on day 7 of two diet conditions - one overfed & one eucaloric condition; weeks 16 & 20). 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 7 Apr 2023.