HealthyPhase 2NCT05058638
Effectiveness of Aquamin® in Mitigating Halitosis
A Phase 2 study testing Aquamin in people with Healthy and Halitosis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- What is being tested?
- Aquamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to Dec 2027
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
Iwonka Eagle, 734-615-8507, ilenda@umich.edu
About this study
Official title: Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
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.
Read the detailed description
This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.
However, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.
- Being tested
- Aquamin
- Keywords
- Aquamin®
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaminDrug
Also called Nutritional
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).
| Study group | Role | What they receive |
|---|---|---|
| Aquamin® | Experimental | Not described Receives: Drug: Aquamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question.
Measured: 90 days (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Aug 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad N Aslam, MD, University of Michigan
- Investigators
- Muhammad N Aslam, Principal investigator, University of MichiganIwonka Eagle, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058638
- Sponsor's protocol ID
- HUM00156676 Halitosis substudy
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
- ClinicalTrials.gov ID
- NCT05058638
- Acronym / sponsor ID
- HUM00156676 Halitosis substudy
- Keywords
- Aquamin®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Sep 2021 (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 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.
Detailed description
This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.
However, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquamin® | Experimental | Drug: Aquamin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| AquaminAlso: NutritionalParticipants 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). | Drug | Aquamin® |
Primary outcome
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
Time frame: 90 days (post-intervention)
Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question.
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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Muhammad N Aslam principal investigator
University of Michigan
Iwonka Eagle study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aquamin in people with Healthy and Halitosis, run by University of Michigan 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 9 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: looking for participants now, as of the sponsor's last update on 28 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 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Muhammad N Aslam (734-936-1897, mnaslam@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Halitosis Associated Life-quality Test (HALT) questionnaire (modified) (time frame: 90 days (post-intervention)). 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 28 Aug 2026.