Effectiveness of Aquamin® in Mitigating Halitosis

NCT05058638 | Active Not Recruiting Phase 2

• 1 other identifier: HUM00156676 Halitosis substudy
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Aquamin®

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days (post-intervention)

Study Arms (1)

Aquamin®

EXPERIMENTAL

Drug: Aquamin

Interventions

Aquamin DRUG

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).

Also known as: Nutritional

Aquamin®

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to not scrape their tongue with a toothbrush, oral hygiene aid, or other utensil during the study participation
• Periodontally stable
• Self-reported halitosis
• A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and subject must agree to use appropriate birth control over the study period.

You may not qualify if:

• 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
• Presence of one or more cavitated carious lesions, untreated dental abscesses (endodontic or periodontal), untreated periodontitis (gum disease), or oral pathologies that may contribute to oral malodor (e.g., candidiasis, erosive gingival conditions)
• Taking any of the following within 30 days (will be eligible after completing 30 days of wash out period):
• Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Halitosis

Interventions

Aquamin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad N Aslam

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Janet Kinney

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 28, 2021
• Study Start: August 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)