NCT02370966

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

3.5 years

First QC Date

February 12, 2015

Last Update Submit

September 25, 2018

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

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

    Once a week over five weeks.

Secondary Outcomes (2)

  • 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.

Study Arms (2)

Potato starch

PLACEBO COMPARATOR

Potato powder will be incorporated in the placebo product.

Dietary Supplement: Berry powder

Berry powder

ACTIVE COMPARATOR

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

Dietary Supplement: Berry powder

Interventions

Berry powderDIETARY_SUPPLEMENT

Berry and gingivitis trial

Also known as: Natural berries
Berry powderPotato starch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kristianstad

Kristianstad, Skåne County, 29188, Sweden

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rutger Persson, PhD, DDS

    University of Kristianstad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 25, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

SE(1)