Overweight and Obese VolunteersWeR-LIM-SMBANCT06745362
Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
A study testing self-monitoring of breath acetone and lifestyle-intervention via LIM-App in people with Overweight and Obese Volunteers, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults. Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obese Volunteers
- What is being tested?
- self-monitoring of breath acetone and lifestyle-intervention via LIM-App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index > 25kg/m2
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.
Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.
Participants will:
Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.
Read the detailed description
Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.
Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.
- Conditions
- Overweight and Obese Volunteers
- Being tested
- self-monitoring of breath acetone, lifestyle-intervention via LIM-App
- Keywords
- lifestyle intervention, weight reduction, ketosis
- Medical subject headings
- Overweight, Weight Loss, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoring of breath acetoneOther
Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.
lifestyle-intervention via LIM-AppOther
Participants are offered a lifestyle intervention via LIM-App.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | lifestyle intervention including information about ketosis level Receives: Other: self-monitoring of breath acetone; Other: lifestyle-intervention via LIM-App |
| control group | Active comparator | lifestyle intervention without information about ketosis level Receives: Other: lifestyle-intervention via LIM-App |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in kg
Measured: 3 months
Secondary outcomes (1)
body weight
body weight in kg
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese VolunteersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745362
- Sponsor's protocol ID
- 20241217
- Acronym
- WeR-LIM-SMBA
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone
- ClinicalTrials.gov ID
- NCT06745362
- Acronym / sponsor ID
- WeR-LIM-SMBA / 20241217
- Conditions
- Overweight and Obese Volunteers
- Keywords
- lifestyle intervention, weight reduction, ketosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2024 (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.
The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.
Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.
Participants will:
Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.
Detailed description
Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.
Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: self-monitoring of breath acetone, Other: lifestyle-intervention via LIM-Applifestyle intervention including information about ketosis level |
| control group | Active comparator | Other: lifestyle-intervention via LIM-Applifestyle intervention without information about ketosis level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index > 25kg/m2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| self-monitoring of breath acetoneParticipants perform self-monitoring of braeth acetone in order to get information about their ketosis state. | Other | Intervention group |
| lifestyle-intervention via LIM-AppParticipants are offered a lifestyle intervention via LIM-App. | Other | Intervention group, control group |
Primary outcome
body weight
Time frame: 3 months
body weight in kg
1 secondary outcome
body weight
Time frame: 12 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 10 Aug 2026.
- Individual participant dataSharing planned: No. upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-monitoring of breath acetone and lifestyle-intervention via LIM-App in people with Overweight and Obese Volunteers, run by West German Center of Diabetes and Health at 1 site in Germany.
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 1 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 10 Aug 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 Germany. 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?
body weight (time frame: 3 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 10 Aug 2026.