Recruiting
Phase 2

Aquamin®

Sponsor:

University of Michigan

Code:

NCT05058638

Conditions

Healthy

Halitosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Aquamin

Study Details

Brief summary:

The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.

Conditions

Healthy

Halitosis

Study ID

NCT05058638

Start date

Aug 15, 2022

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Must be able to give written informed consent
  • Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visits
  • Have stable oral health
  • Self-reported halitosis
  • A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and the subject must agree to use appropriate birth control over the study period.

Exclusion Criteria:

  • Pregnant or lactating women
  • Participating in any other interventional trials using an investigational drug
  • Diagnosed with any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors) or active gastric/duodenal ulcers - peptic ulcer disease (in last 3 months) or with severe symptoms of ulcerative colitis or Crohn's disease
  • Any gastrointestinal or colonic malignancy; kidney disease, including kidney "stones" or hypercalcemia
  • Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin
  • Have any severe oral condition that, in the opinion of the oral healthcare provide might impact the results of the study if the condition is treated
  • Have been treated for oral cancer within the past year
  • Taking any of the following within 30 days (will be eligible after completing 30 days of washout period):

Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aquamin®

Interventions

Aquamin

Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).

Primary outcome measure

  • Halitosis Associated Life-quality Test (HALT) questionnaire (modified) [ Time Frame: 90 days (post-intervention) ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan School of Dentistry

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

More Information

Sponsor

University of Michigan

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Aquamin®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-28.