Carbonic Anhydrase Inhibitors and Carbonation: A Novel Approach to Reduce Soda Consumption

NCT06110078 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: STUDY00003535
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Soda intake

  Total soda/carbonated beverage intake per week

  3 weeks

Secondary Outcomes (1)

• Weight

  3 weeks

Study Arms (4)

Group 1

EXPERIMENTAL

Daily oral acetazolamide mouth rinse 10 ml

Drug: Acetazolamide

Group 2

EXPERIMENTAL

Twice daily oral acetazolamide mouth rinse 10 ml

Drug: Acetazolamide

Group 3

PLACEBO COMPARATOR

Placebo mouth wash daily 10 ml

Drug: Acetazolamide

Group 4

PLACEBO COMPARATOR

Twice daily placebo mouth wash 10 ml

Drug: Acetazolamide

Interventions

Acetazolamide DRUG

Oral rinse with acetazolamide (not taken orally)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women.
• Prisoners.
• Refugees.
• Cognitive impairment.
• Chronic illness.
• Allergy to sulfa drugs or aspirin.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

College of Medicine Phoenix U of Arizona

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: January 18, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

US (1)