ObesityEarly Phase 1NCT06110078
Carbonic Anhydrase Inhibitors and Carbonation: A Novel Approach to Reduce Soda Consumption
A Early Phase 1 study testing Acetazolamide in people with Obesity, run by University of Arizona at 1 site in United States.
Trial summary
Acetazolamide is a drug that is approved by the FDA for treating various conditions like epilepsy, altitude sickness, and glaucoma. Acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which is important for many essential processes in our body. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 1 May 2024
- Phase
- Early Phase 1
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Consumes on average ≥ 7 sodas per week
- Healthy and without a history of significant neurological, liver, renal, cardiac or pulmonary disease.
- No allergy to sulfa drugs or aspirin (contained in Alka Seltzer).
- Ability to provide informed consent.
Who cannot join
- Healthy adults, UA students, UA faculty and staff Exclusion Criteria:
- Pregnant or lactating women.
- Prisoners.
- Refugees.
- Cognitive impairment.
- Chronic illness.
- Allergy to sulfa drugs or aspirin.
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Medicine Phoenix U of Arizona
Phoenix, Arizona, 85004
About this study
Acetazolamide is a drug that is approved by the FDA for treating various conditions like epilepsy, altitude sickness, and glaucoma. Acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which is important for many essential processes in our body. For example, carbonic anhydrase is needed to transport carbon dioxide in our blood which is essential for respiration.
One of the interesting effects of acetazolamide is that it reduces the taste of carbonation, making carbonated drinks like soda taste flat and or like soapy water. This effect has been noticed by hikers using the drug for mountain sickness treatment. It's believed that carbonic anhydrase inhibitors decrease the levels of carbonic acid in our mouths, which in turn reduces and changes the perception of carbonation taste.
Read more
It was hypothesized that this side effect of acetazolamide could be used to help people cut down on soda consumption. Since soda has been linked to health issues like obesity and type 2 diabetes, reducing its intake could be beneficial. In a case study, a person who took low-dose acetazolamide for six weeks experienced weight loss and found it easier to avoid carbonated drinks.
We are proposing a study to explore the effects of using acetazolamide as an oral rinse to decrease soda intake. The use of acetazolamide as an oral rinse has yet to be tested and is a possible way to decrease the taste of carbonation while also decreasing the side effects of the drug. Our plan is to use different doses of the rinse on participants and monitor their soda consumption and body mass index changes.
In summary, acetazolamide, a drug with various medical uses, could potentially help people reduce soda consumption by altering the taste of carbonation.
- Conditions
- Obesity
- Being tested
- Acetazolamide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Oral rinse with acetazolamide (not taken orally)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Daily oral acetazolamide mouth rinse 10 ml Receives: Drug: Acetazolamide |
| Group 2 | Experimental | Twice daily oral acetazolamide mouth rinse 10 ml Receives: Drug: Acetazolamide |
| Group 3 | Placebo comparator | Placebo mouth wash daily 10 ml Receives: Drug: Acetazolamide |
| Group 4 | Placebo comparator | Twice daily placebo mouth wash 10 ml Receives: Drug: Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soda intake
Total soda/carbonated beverage intake per week
Measured: 3 weeks
Secondary outcomes (1)
Weight
BMI/weight
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start18 Jan 2024
- Primary completion1 May 2024 (estimated)
- Study completion1 May 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 ArizonaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. William Heise MD, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110078
- Sponsor's protocol ID
- STUDY00003535
- Status last verified
- May 2024
- First submitted
- 25 Oct 2023
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbonic Anhydrase Inhibitors and Carbonation: A Novel Approach to Reduce Soda Consumption
- ClinicalTrials.gov ID
- NCT06110078
- Acronym / sponsor ID
- STUDY00003535
- Conditions
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 31 Oct 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.
Acetazolamide is a drug that is approved by the FDA for treating various conditions like epilepsy, altitude sickness, and glaucoma. Acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which is important for many essential processes in our body. For example, carbonic anhydrase is needed to transport carbon dioxide in our blood which is essential for respiration.
One of the interesting effects of acetazolamide is that it reduces the taste of carbonation, making carbonated drinks like soda taste flat and or like soapy water. This effect has been noticed by hikers using the drug for mountain sickness treatment. It's believed that carbonic anhydrase inhibitors decrease the levels of carbonic acid in our mouths, which in turn reduces and changes the perception of carbonation taste.
It was hypothesized that this side effect of acetazolamide could be used to help people cut down on soda consumption. Since soda has been linked to health issues like obesity and type 2 diabetes, reducing its intake could be beneficial. In a case study, a person who took low-dose acetazolamide for six weeks experienced weight loss and found it easier to avoid carbonated drinks.
We are proposing a study to explore the effects of using acetazolamide as an oral rinse to decrease soda intake. The use of acetazolamide as an oral rinse has yet to be tested and is a possible way to decrease the taste of carbonation while also decreasing the side effects of the drug. Our plan is to use different doses of the rinse on participants and monitor their soda consumption and body mass index changes.
In summary, acetazolamide, a drug with various medical uses, could potentially help people reduce soda consumption by altering the taste of carbonation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AcetazolamideDaily oral acetazolamide mouth rinse 10 ml |
| Group 2 | Experimental | Drug: AcetazolamideTwice daily oral acetazolamide mouth rinse 10 ml |
| Group 3 | Placebo comparator | Drug: AcetazolamidePlacebo mouth wash daily 10 ml |
| Group 4 | Placebo comparator | Drug: AcetazolamideTwice daily placebo mouth wash 10 ml |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Consumes on average ≥ 7 sodas per week
- Healthy and without a history of significant neurological, liver, renal, cardiac or pulmonary disease.
- No allergy to sulfa drugs or aspirin (contained in Alka Seltzer).
- Ability to provide informed consent.
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- Prisoners.
- Refugees.
- Cognitive impairment.
- Chronic illness.
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 |
|---|---|---|
| AcetazolamideOral rinse with acetazolamide (not taken orally) | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Soda intake
Time frame: 3 weeks
Total soda/carbonated beverage intake per week
1 secondary outcome
Weight
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 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.
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 Early Phase 1 study testing Acetazolamide in people with Obesity, run by University of Arizona 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 5 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 7 May 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Soda intake (time frame: 3 weeks). 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 May 2024.