The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis (ENURGISE)

The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries (Juice Plus+) Upon Periodontal Outcomes in Chronic Periodontitis: A Multicentre Randomised Controlled Trial

The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to standard non-surgical treatment.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Dietary supplement: Placebo non active capsules; Dietary supplement: Juice plus+

Detailed Description

The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to non-surgical treatment. In addition, the effects of supplementation prior to and following standard non-surgical management will be assessed, relative to a placebo supplemented group.

The investigators hypothesize that 3-months of nutritional support using this FVB will result in additional reductions in marginal gingival inflammation (bleeding) and additional reductions in probing pocket depth (mean & cumulative), over and above any placebo-related or behavioral effect. In addition, the investigators hypothesize that 3-months of nutritional support prior to a standard non-surgical therapy in conjunction with a continuation of the nutritional support for 3 months will result in further additional reductions in marginal gingival inflammation and probing pocket depth, over and above any placebo-related or behavioral effect following standard non-surgical therapy.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, D-97070
    • University of Wuerzburg
• Netherlands
  • Amsterdam, Netherlands, 1066 EA
    • Academic Centre for Dentistry
• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 6NN
      • Birmingham Dental Hospital & School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be aged 18 years old and over
• have a minimum of 20 teeth
• have chronic periodontitis
• be capable of giving informed consent themselves

Exclusion Criteria:

• Patients with aggressive disease
• Patients with physical or mental disability
• Pregnant women or those breastfeeding
• Patients whose medical history may place them at risk of complications from periodontal therapy (e.g. warfarinised Volunteers)
• Patients taking long term anti-microbial or anti-inflammatory drugs
• Patients unable to swallow the study capsules, or take 6 of these capsules a day
• Patients unable to provide informed consent
• Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils) or have taken them within 1-month of the study
• Shows unwillingness, inability or lack of motivation to carry out the study procedures or is not prepared to give written consent or to refrain from using other oral hygiene products (mouthwashes, chewing gum, water piks etc.) or to undergo professional dental cleaning for the duration of the study (other than as part of this protocol)
• Antibiotic or anti-inflammatory therapy currently or in previous two weeks
• Current orthodontic treatment
• Currently participating in another Dental Trial
• Diabetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Supplementation with non-active; Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm)	Dietary supplement: Placebo non active capsules; Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
Active Comparator: Dietary supplementation with Juice plus+; Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm)	Dietary supplement: Juice plus+; Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in clinical parameters	The primary outcomes will be differences in the changes in the below parameters at 3-months post-supplementation between test and placebo groups: % sites with marginal bleeding on probing (BOP) from baseline.; Probing pocket depth reductions (mm) from baseline (expressed as reductions in mean and also cumulative pocket depth).	3 months
Changes in clinical parameters	The primary outcomes will be differences in the changes in the parameters listed below at 6 months (3 months post supplementation + 3 months post treatment)in test and placebo groups % sites with marginal BOP from baseline. Probing pocket depth reductions (mm) from baseline (expressed as reductions in mean and also cumulative pocket depth).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and biochemical changes	Secondary outcome measures will be clinical and biochemical and include differences in the changes in the below between test and placebo groups: Patient outcomes - oral health quality of life; Clinical outcomes - % sites BOP from pocket base from baseline, clinical attachment level (CAL) measures (mm), recession (mm), gingival redness (MGI).; Biochemical outcomes in plasma -carbonyls, 8OHdG (from buffy coats), isoprostanes, vitamin C, beta-carotene	3 months
Clinical and biochemical changes	Secondary outcome measures will be clinical and biochemical and include differences in the changes in the below between test and placebo groups: Patient outcomes - oral health quality of life Clinical outcomes - % sites BOP from pocket base from baseline, CAL measures (mm), recession (mm), gingival redness (MGI). Biochemical outcomes in plasma -carbonyls, 8OHdG (from buffy coats), isoprostanes, vitamin C, beta-carotene	6 months

Collaborators and Investigators

• Sponsor: Birmingham Community Healthcare NHS
• Collaborators: University of Wuerzburg; Academic Centre for Dentistry in Amsterdam
• Investigators: Principal Investigator: Iain L Chapple, BDS, PhD, University of Birmingham; Principal Investigator: Ulrich Schlagenhauf, PhD, University of Wuerzburg; Principal Investigator: Ubele Van der Velden, PhD, Academic Centre for Dentistry in Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): September 27, 2017

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 28, 2010

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Periodontitis; Dietary supplementation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: MULTI-NSA-10-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No