NCT00952536

Brief Summary

There are 3 hypotheses to be tested:

  1. 1.That daily supplementation with Juice Plus+ will significantly improve treatment outcomes over placebo supplementation, at 3-months post-therapy, when used as an adjunct to conventional non-surgical periodontal therapy.
  2. 2.Triple therapy with Juice Plus+ (fruit, vegetable \& berry) will produce additional treatment benefit over dual therapy (fruit \& vegetable) and over placebo.
  3. 3.Improved treatment outcomes with Juice Plus+ will be maintained at 9-months post-therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

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, 2005

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

5.3 years

First QC Date

August 3, 2009

Last Update Submit

February 13, 2017

Conditions

Periodontitis

Keywords

Randomised controlled trialDouble blind fully maskedDietary supplement

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months.

    3, 6 and 9-months

Secondary Outcomes (1)

  • Secondary outcome measures will be reduction in % sites with disclosed plaque (PS - measured dichotomously at 4 sites per tooth), reductions in gingival crevicular fluid (GCF) volume, increases in GCF and plasma TAOC.

    3, 6 and 9-months

Study Arms (3)

Triple therapy

ACTIVE COMPARATOR

Daily Juice Plus+ with 2 vegetable \& 2 fruit \& 2 berry capsule (test group 1)

Dietary Supplement: Daily Juice Plus+ with vegetable & fruit & berry capsule

Dual Therapy

ACTIVE COMPARATOR

Juice Plus+ with 2 vegetable \& 2 fruit \& 2 placebo capsule (test group 2)

Dietary Supplement: Daily Juice Plus+ vegetable & fruit & placebo capsule

Control

PLACEBO COMPARATOR

Daily Placebo in the form of 6 capsules (control group)

Dietary Supplement: Placebo in the form of 6 capsules

Interventions

Daily Juice Plus+ with vegetable & fruit & berry capsuleDIETARY_SUPPLEMENT

Daily Juice Plus+ with 2 vegetable \& 2 fruit \& 2 berry capsule

Also known as: Daily Juice Plus+ Fruit, Vegetable and Vineyard
Triple therapy
Daily Juice Plus+ vegetable & fruit & placebo capsuleDIETARY_SUPPLEMENT

Daily Juice Plus+ with vegetable \& fruit \& placebo capsule

Also known as: Juice Plus+ Vegetable & Fruit & placebo capsule
Dual Therapy
Placebo in the form of 6 capsulesDIETARY_SUPPLEMENT

Daily Placebo in the form of 6 capsules (control group)

Also known as: Placebo
Control

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic periodontitis
  • Presence of 2 or more sites per quadrant with pocketing or interproximal attachment loss of greater than 6mm and 1/3rd radiographic bone loss

You may not qualify if:

  • Subjects with aggressive disease
  • Subjects with physical or mental disability
  • Pregnant women
  • Subjects whose medical history may place them at risk of complications from periodontal therapy (e.g. need for antibiotic cover, warfarinised subjects)
  • Subjects taking long term anti-microbial or anti-inflammatory drugs
  • Subjects unable to swallow Juice Plus+ capsules
  • Subjects unable to provide informed consent
  • Current smokers
  • Subjects taking regular vitamin supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Dental Hospital & Scool

Birmingham, West Midlands, B4 6NN, United Kingdom

Location

Related Publications (1)

  • Chapple IL, Milward MR, Ling-Mountford N, Weston P, Carter K, Askey K, Dallal GE, De Spirt S, Sies H, Patel D, Matthews JB. Adjunctive daily supplementation with encapsulated fruit, vegetable and berry juice powder concentrates and clinical periodontal outcomes: a double-blind RCT. J Clin Periodontol. 2012 Jan;39(1):62-72. doi: 10.1111/j.1600-051X.2011.01793.x. Epub 2011 Oct 17.

    PMID: 22093005DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

VegetablesFruitFarms

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAgricultureTechnology, Industry, and AgricultureManufacturing and Industrial FacilitiesNon-Medical Public and Private Facilities

Study Officials

  • Iain LC Chapple, BDS FDS PhD

    The University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (PI for study)

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

February 1, 2005

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

GB(1)