Effect of Dietary Intake of Dried Whole Food Concentrates (Juice Plus) on Clinical Outcomes Following Periodontal Therapy: A Pilot Study (BHAM-NSA-05-01)

This study has been completed.
Sponsor:
Collaborator:
NSA, LLC
Information provided by (Responsible Party):
Professor I Chapple, NHS South Birmingham
ClinicalTrials.gov Identifier:
NCT00952536
First received: August 3, 2009
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

There are 3 hypotheses to be tested:

  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. Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional treatment benefit over dual therapy (fruit & vegetable) and over placebo.
  3. Improved treatment outcomes with Juice Plus+ will be maintained at 9-months post-therapy.

Brief Summary:

Periodontal diseases are highly prevalent chronic inflammatory diseases and a major cause of tooth loss. Data supports an association between periodontitis prevalence and reduced serum levels of antioxidants. Anecdotal reports from periodontal specialists indicate significant improvements in clinical outcomes from periodontal therapy where adjunctive Juice Plus+ is used, in agreement with research data from other systemic diseases where hyper-inflammation is implicated in disease pathogenesis. There is however, a lack of scientific evidence from clinical trials of periodontitis. Given the demonstrable antioxidant deficiency in periodontitis patients (both locally and peripherally), the excess oxidative stress in periodontitis patients, and the anecdotal evidence of clinical benefit from the adjunctive use of Juice Plus+, this study proposes to investigate the impact of daily supplementation with Juice Plus+ as an adjunct to traditional non-surgical periodontal therapy, in improving therapeutic outcomes.


Condition Intervention Phase
Periodontitis
Dietary Supplement: Daily Juice Plus+ with vegetable & fruit & berry capsule
Dietary Supplement: Daily Juice Plus+ vegetable & fruit & placebo capsule
Dietary Supplement: Placebo in the form of 6 capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Daily Dietary Intake of Dried Whole Food Concentrates of Fruit, Vegetables and Berries (Juice Plus+) in Improving Clinical Outcomes Following Non-surgical Periodontal Therapy: a Pilot Study.

Further study details as provided by NHS South Birmingham:

Primary Outcome Measures:
  • Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months. [ Time Frame: 3, 6 and 9-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3, 6 and 9-months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2005
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triple therapy
Daily Juice Plus+ with 2 vegetable & 2 fruit & 2 berry capsule (test group 1)
Dietary Supplement: Daily Juice Plus+ with vegetable & fruit & berry capsule
Daily Juice Plus+ with 2 vegetable & 2 fruit & 2 berry capsule
Other Name: Daily Juice Plus+ Fruit, Vegetable and Vineyard
Active Comparator: Dual Therapy
Juice Plus+ with 2 vegetable & 2 fruit & 2 placebo capsule (test group 2)
Dietary Supplement: Daily Juice Plus+ vegetable & fruit & placebo capsule
Daily Juice Plus+ with vegetable & fruit & placebo capsule
Other Name: Juice Plus+ Vegetable & Fruit & placebo capsule
Placebo Comparator: Control
Daily Placebo in the form of 6 capsules (control group)
Dietary Supplement: Placebo in the form of 6 capsules
Daily Placebo in the form of 6 capsules (control group)
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952536

Locations
United Kingdom
Birmingham Dental Hospital & Scool
Birmingham, West Midlands, United Kingdom, B4 6NN
Sponsors and Collaborators
NHS South Birmingham
NSA, LLC
Investigators
Principal Investigator: Iain LC Chapple, BDS FDS PhD The University of Birmingham
  More Information

No publications provided by NHS South Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor I Chapple, Professor (PI for study), NHS South Birmingham
ClinicalTrials.gov Identifier: NCT00952536     History of Changes
Other Study ID Numbers: BHAM-NSA-05-001 vs 11
Study First Received: August 3, 2009
Last Updated: September 24, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS South Birmingham:
Randomised controlled trial
Double blind fully masked
Dietary supplement

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014