Weight LossNCT05139420
Risk of Metabolic Adaptation After Weight Loss
A study testing lifestyle intervention with meal replacement program in people with Weight Loss and Obesity, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- lifestyle intervention with meal replacement program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2022to Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > or = 30 any ethnicity
Who cannot join
- weight > or = 400 lbs.
- diabetes (type 2 or type 1)
- hypertension
- heart disease
- kidney disease
- liver disease
Show all 13Show fewer
- active cancer
- post solid organ or bone marrow transplant
- HIV/AIDS
- pregnancy
- breastfeeding
- current smoker
- current recreational drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.
- Conditions
- Weight Loss, Obesity
- Being tested
- lifestyle intervention with meal replacement program
- Keywords
- resting metabolic rate, metabolic adaptation
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle intervention with meal replacement programOther
participants will be enrolled in a medical weight loss program and will be given a 6 month subscription to a calorie-reduced meal replacement program, in addition to lifestyle advice.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching. Receives: Other: lifestyle intervention with meal replacement program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in measured and predicted resting metabolic rate during and after weight loss
resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points
Measured: 18 months
Secondary outcomes (7)
change in circulating leptin during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in circulating thyroid hormones during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in circulating GLP-1 during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in circulating PYY during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in circulating AgRP during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in 24h urine catecholamines during and after weight loss
urine will be assayed for these hormones every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
change in heart rate variability during and after weight loss
blood will be assayed for this hormone every 2 months for 6 months, then every 6 months for an additional 12 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start10 Sep 2022
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Morselli, MD PhD, Medical College of Wisconsin
- Investigators
- Lisa L Morselli, MD PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139420
- Sponsor's protocol ID
- PRO00039217
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
- ClinicalTrials.gov ID
- NCT05139420
- Acronym / sponsor ID
- PRO00039217
- Conditions
- Weight Loss, Obesity
- Keywords
- resting metabolic rate, metabolic adaptation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 1 Dec 2021 (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 study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Other: lifestyle intervention with meal replacement programParticipants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI > or = 30 any ethnicity
Key exclusion criteria (13 listed)
- weight > or = 400 lbs.
- diabetes (type 2 or type 1)
- hypertension
- heart disease
- kidney disease
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 |
|---|---|---|
| lifestyle intervention with meal replacement programparticipants will be enrolled in a medical weight loss program and will be given a 6 month subscription to a calorie-reduced meal replacement program, in addition to lifestyle advice. | Other | lifestyle intervention |
Primary outcome
change in measured and predicted resting metabolic rate during and after weight loss
Time frame: 18 months
resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points
7 secondary outcomes
change in circulating leptin during and after weight loss
Time frame: 18 months
change in circulating thyroid hormones during and after weight loss
Time frame: 18 months
change in circulating GLP-1 during and after weight loss
Time frame: 18 months
change in circulating PYY during and after weight loss
Time frame: 18 months
change in circulating AgRP during and after weight loss
Time frame: 18 months
change in 24h urine catecholamines during and after weight loss
Time frame: 18 months
change in heart rate variability during and after weight loss
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Lisa L Morselli, MD PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention with meal replacement program in people with Weight Loss and Obesity, run by Medical College of Wisconsin 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 1 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in measured and predicted resting metabolic rate during and after weight loss (time frame: 18 months). 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 11 Feb 2026.