Effect of Dietary Intake of Dried Whole Food Concentrates (Juice Plus) on Clinical Outcomes Following Periodontal Therapy: A Pilot Study (BHAM-NSA-05-01)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by NHS South Birmingham.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
NHS South Birmingham
Collaborator:
NSA, LLC
Information provided by:
NHS South Birmingham
ClinicalTrials.gov Identifier:
NCT00952536
First received: August 3, 2009
Last updated: July 21, 2010
Last verified: October 2009
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Purpose
There are 3 hypotheses to be tested:
- 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.
- Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional treatment benefit over dual therapy (fruit & vegetable) and over placebo.
- 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. |
Resource links provided by NLM:
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 |
| Estimated Study Completion Date: | December 2010 |
| Estimated 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
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 Iain L C Chapple, The University of 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: | July 21, 2010 |
| 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 May 23, 2013