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Dietary Fiber and Gum Health: A Trial in Healthy Volunteers

The impact of dietary fibre supplementation on gum disease; A randomised control trial in healthy volunteers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001067662
Acronym
Fib-Gum Trial
Enrollment
75
Registered
2023-10-05
Start date
2024-01-08
Completion date
2024-06-03
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The prevalence of chronic diseases linked to inflammation has prompted a need for understanding its impact. Gum disease (GD), a chronic inflammatory condition affecting oral tissues, shares links with systemic inflammatory diseases. GD's effects aren't confined to the mouth; they can impact overall health and carry socio-economic burdens. GD's global prevalence, including a significant presence in Australia, emphasizes the need for investigation. GD offers an accessible model to study interventions for chronic inflammatory diseases due to its manageable accessibility, representation of both soft and hard tissues, and rapid inflammation response. GD's reversibility, ability to measure inflammatory markers, and its connection with systemic diseases further support its model suitability. Diet, a modifiable human aspect, plays a role in inflammation. Studies reveal dietary effects on GD, with low-fiber diets possibly contributing to higher GD prevalence. Dietary fibers, fermented by gut microbes, produce short chain fatty acids (SCFAs) like acetate, which inhibits pro-inflammatory responses. SCFAs such as butyrate and propionate also show potential anti-inflammatory effects. Despite this, many Australians fall short of recommended fiber intake. To address this, fiber supplementation becomes a potential solution. No comprehensive research on dietary fiber's impact on GD and SCFAs has been conducted. This project aims to test dietary fiber's effects on gum health, hypothesizing that reducing inflammation through fiber intake could improve gum health and potentially reduce the risk of inflammation-related chronic diseases. This research bridges nutritional immunology with oral health, holding implications for chronic diseases beyond gum health. The hypothesis suggests that increasing dietary fiber through a prebiotic supplement could lead to milder GD symptoms due to anti-inflammatory short chain fatty acids. The objective is to assess the effects of fiber supplementation on gum health using an experimental gum disease model in healthy individuals without existing gum disease.

Interventions

For the participants in this study, the intervention involves the following four different fibre regimens: (1) psyllium husk, (2) inulin, (3) Konjac root-Glucomannan, and (4) a mixture of psyllium husk, inulin, and Konjac root-Glucomannan in a 1:1:1 ratio. Each participant will take a dose of 25g daily for a duration of 3 months and 21 days. The fibre supplements will be administered orally, mixed in 300mL of water, and participants will self-administer them, before brushing the teeth in the mor

For the participants in this study, the intervention involves the following four different fibre regimens: (1) psyllium husk, (2) inulin, (3) Konjac root-Glucomannan, and (4) a mixture of psyllium husk, inulin, and Konjac root-Glucomannan in a 1:1:1 ratio. Each participant will take a dose of 25g daily for a duration of 3 months and 21 days. The fibre supplements will be administered orally, mixed in 300mL of water, and participants will self-administer them, before brushing the teeth in the morning. To monitor adherence to the intervention, we will utilise a food frequency questionnaire to assess dietary intake at baseline and after the pause in tooth brushing. Additionally, a supplementation compliance form on Redcap will be used to track compliance with fibre supplementation. This study is designed as a randomised controlled trial. Regarding the experimental gum disease model, it aims to simulate early-stage gum disease (a precursor to periodontitis) in healthy individuals. This model replicates the natural process of bacterial build-up on tooth surfaces due to the absence of toothbrushing, resulting in gum inflammation. To induce this experimental gum disease, participants will temporarily cease oral hygiene activities in the upper right side of the jaw (Quadrant I) for a period of 21 days (the last 21 days of the intervention period, i.e. 3 months and 21 days). During this time, participants will continue to brush the other three quadrants of their mouth with a toothbrush only (no toothpaste or mouthwash or any other product), ensuring that no anti-inflammatory effects are introduced by these products. This model allows us to study the impact of dietary factors on oral inflammation in otherwise healthy individuals.

Sponsors

Professor Axel Spar
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

We will recruit non-smoking, healthy (no cardiometabolic disease or gastrointestinal conditions or diabetes) participants (18-35 years old) with a minimum of 20 teeth and no clinical gingivitis (redness, swelling, bleeding), no probing pocket depth greater than or equal 3 mm at any site, no approximal attachment loss greater than or equal 2mm at any site and gingival index (GI)=0 at baseline from a pool of University staff and students registered as potential study participants.

Exclusion criteria

Participants with less than 20 teeth and have clinical gingivitis (redness, swelling, bleeding), probing pocket depth greater than or equal 3mm at any site, approximal attachment loss greater than or equal 2mm at any site, and gingival index (GI)= or >1 will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026