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

NCT00952536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-14

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis

Interventions

DIETARY_SUPPLEMENT

Daily Juice Plus+ with vegetable & fruit & berry capsule

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

DIETARY_SUPPLEMENT

Daily Juice Plus+ vegetable & fruit & placebo capsule

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

DIETARY_SUPPLEMENT

Placebo in the form of 6 capsules

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

Sponsors & Collaborators

  • NSA, LLC

    collaborator INDUSTRY

  • Birmingham Community Healthcare NHS

    lead OTHER_GOV

Principal Investigators

  • Iain LC Chapple, BDS FDS PhD · The University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00952536 on ClinicalTrials.gov