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Clinical Trials/NCT02370966
NCT02370966CompletedPhase 1

Berry Intake - Effects on Systemic and Oral Inflammation

Kristianstad University2 sites in 1 country18 target enrollmentStarted: February 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Changes in the extent of gingivitis, as determined by severity of gingival bleeding, before and after study procedures.

Study Overview

Brief Summary

The purpose of this study is to determine whether intake of berry powder effective in the treatment of systemic and oral inflammation.

Detailed Description

Summary About 10-15 % of the adult population in Sweden suffers from periodontitis, which is an inflammatory response to certain oral bacteria. The first stage of periodontitis is termed gingivitis, which is clinically defined by swollen tissue, redness and bleeding in the gingiva. If the inflammatory process could be attenuated, this would greatly reduce the risk of developing periodontitis.

Diet is of importance for the development and prevention of chronic diseases. Berries contain compounds that can act as anti-inflammatory agents and this bioactivity may reduce the risk of disease. A recent meta-analysis of publications in this area revealed a dearth of experimental and clinical data on the impact of berry intake on inflammatory conditions. Studies which detail berry intake/dosage and period of dosage to exert an effect is particularly lacking, in terms of the positive effects of berries on anti-inflammatory conditions. The purpose of this project is to:

  • Demonstrate the impact of daily intake of freeze-dried berries on the clinical degree of chronic inflammation by studying changes in the degree of gingivitis.
  • To study the presence of pro- and anti-inflammatory markers locally in gingival tissue, saliva and through analysis of serum samples.
  • To analyze dose response relationship for different berry powders by investigating clinical and biomedical effect.

Background Many diseases have a significant inflammatory pathogenesis which can be difficult to control. In traditional medicine symptoms and inflammatory processes are treated with pharmaceuticals. Many pharmaceuticals show side-effects that have economic and environmental consequences both for the individual and the environment. It has for centuries been known that plants have anti-inflammatory and healing effects. An early example of how plants came in use for medical treatment is the work of Carl von Linné and his practice as a botanist and physician.

In modern times complimentary alternative medicine has claimed that intake of fruit and berries in different compositions has anti-inflammatory effects. Some of these claims have been difficult to evaluate since studies to highlight anti-inflammatory benefit have often not been well conducted. There is a conspicuous lack of data on clinically effective doses of plant extracts. The Swedish National Food Agency contends that the daily intake of vegetables, fruits and berries should be 500 grams for adults, although few people in Sweden reach these recommendations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • minimum of 20 teeth
  • bleeding on probing >25 %
  • participate in routine dental examinations

Exclusion Criteria

  • on anti-inflammatory medication
  • current treatment with antibiotics or intake of antibiotics 3 months before participating in the study
  • pregnancy
  • unwilling to refrain from nutraceuticals during the study period
  • unwilling to give detailed information on diet intake during the study period

Arms & Interventions

Potato starch

Placebo Comparator

Potato powder will be incorporated in the placebo product.

Intervention: Berry powder (Dietary Supplement)

Berry powder

Active Comparator

Several different berry powders including rose hip, bilberry, blackcurrant, sea buckthorn, and lingonberry will be prepared and studied.

Intervention: Berry powder (Dietary Supplement)

Outcomes

Primary Outcomes

Changes in the extent of gingivitis, as determined by severity of gingival bleeding, before and after study procedures.

Time Frame: Once a week over five weeks.

Secondary Outcomes

  • Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to gingival inflammation, as determined by severity of gingival bleeding, before and after study procedures.(Once a week over five weeks.)
  • Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to amount of berry intake before and after study procedures.(Once a week over five weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Widen

Researcher

Kristianstad University

Study Sites (2)

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