AdiposityNCT06153654
Role of the Nasal Environment in Obesity
An observational study of Adiposity, run by Katharina Timper at 1 site in Switzerland.
Trial summary
The primary aim of this study is to investigate the nasal environment in obese and lean individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Adiposity
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jul 2021to Sep 2025
- Phase
- Observational
- 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 55 years
- All sexes
- Adult
Study population: Male and female participants between the age of 18-55. 50 participants with obesity, 50 lean participants (age- and sex-matched), 50 patients with schedueled bariatric surgery
Who may be able to join
- N=50 adult male and female patients with obesity will be included in this study.
- Age 18-55 years
- Written informed consent
- BMI > 30 kg/m2
- N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.
- Age 18-55 years
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- Written informed consent
- BMI 18-25 kg/m2
- N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study
- Age 18-55 years
- Written informed consent
- BMI > 35 kg/m2
Who cannot join
- Smoking
- Chronic or acute sinusitis
- Surgical intervention of the nasal cavity or the paranasal sinus
- Use of antibiotics within the last 31 days18
- Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
- Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
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- Use of any kind of decongestant more than twice a week
- Use of cortisone-containing nasal spray within the last 3 months
- Acute allergic rhinitis
- History of neurodegenerative diseases
- History of severe head trauma
- Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel
Katharina Timper, Prof.Dr.med., +41 61 328 57 42, katharina.timper@usb.ch
Anouk Hoogkamer, +41 61 328 55 20, anouklisa.hoogkamer@usb.ch
About this study
Official title: Role of the Nasal Microbiota in Obesity - the microNASA Study
The primary aim of this study is to investigate the nasal environment in obese and lean individuals.
- Conditions
- Adiposity
- Keywords
- Adiposity, Olfactory Function, Microbiome
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Obese participants with BMI >30 | |
| Lean | Lean participants with a BMI <25 | |
| Bariatric | Participants with scheduled bariatric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in nasal microbiota composition
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as the difference in nasal microbiome in obese vs. sex- and age-matched lean control individuals.
Measured: 6 Months
Secondary outcomes (1)
Change in nasal microbiota Composition after bariatric surgery
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as changes in nasal microbiome in obese patients before and 1, 3, 6 and 12 month after bariatric surgery.
Measured: 24 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 2023
- Study start30 Jul 2021
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katharina Timper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katharina Timper, University Hospital, Basel, Switzerland
- Investigators
- Katharina Timper, Prof. Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153654
- Sponsor's protocol ID
- 2021-01090
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Nasal Microbiota in Obesity - the microNASA Study
- ClinicalTrials.gov ID
- NCT06153654
- Acronym / sponsor ID
- 2021-01090
- Conditions
- Adiposity
- Keywords
- Adiposity, Olfactory Function, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Katharina TimperUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Dec 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.
The primary aim of this study is to investigate the nasal environment in obese and lean individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese | – | –Obese participants with BMI >30 |
| Lean | – | –Lean participants with a BMI <25 |
| Bariatric | – | –Participants with scheduled bariatric surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Male and female participants between the age of 18-55. 50 participants with obesity, 50 lean participants (age- and sex-matched), 50 patients with schedueled bariatric surgery
Key inclusion criteria (12 listed)
- N=50 adult male and female patients with obesity will be included in this study.
- Age 18-55 years
- Written informed consent
- BMI > 30 kg/m2
- N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.
Key exclusion criteria (12 listed)
- Smoking
- Chronic or acute sinusitis
- Surgical intervention of the nasal cavity or the paranasal sinus
- Use of antibiotics within the last 31 days18
- Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in nasal microbiota composition
Time frame: 6 Months
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as the difference in nasal microbiome in obese vs. sex- and age-matched lean control individuals.
1 secondary outcome
Change in nasal microbiota Composition after bariatric surgery
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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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.
Katharina Timper, Prof. Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, run by Katharina Timper at 1 site in Switzerland.
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 12 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 1 Dec 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 Switzerland. 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 Katharina Timper, Prof. Dr. med. (+41 61 328 57 42, katharina.timper@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in nasal microbiota composition (time frame: 6 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 1 Dec 2023.