Condition category
Musculoskeletal Diseases
Date applied
23/02/2010
Date assigned
17/03/2010
Last edited
17/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Romulus Scorei

ORCID ID

Contact details

a.i.cuza no.13
Craiova
200385
Romania
+40 (0)251 41 59 60
romulusscorei@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Research Project no.12/2008

Study information

Scientific title

A double-blind, placebo-controlled pilot study to evaluate FruitexB® (calcium fructoborate) effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis

Acronym

FruiteB

Study hypothesis

The safe and efficacious use of the FruitexB® (chemical natural-identical plant based dietary boron) in other inflammatory diseases prompted us to do this study of its anti-inflammatory effects in patients with osteoarthritis (OA) symptoms. The main objective of this approach was to evaluate whether or not FruitexB®, in a double-blind, placebo-controlled, randomly allocated trial with patients suffering from knee osteoarthritis symptoms, may cause any statistically significant favourable effect on systemic inflammation and dyslipidemia markers when compared with the placebo group.

Ethics approval

Institutional Ethics Committee of the University of Medicine and Pharmacy of Craiova, Romania, approved in March 2008 (ref: 364/2008). The trial is also in compliance with the Helsinki Declaration of 1975 as revised in 1983.

Study design

Randomised double-blind placebo-controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary osteoarthritis

Intervention

The study was double-blind and placebo-controlled. For ease of presentation the four subject groups are given the following descriptors:
Group 1: 30 mg FruitexB® twice per day
Group 2: 60 mg FruitexB® twice per day
Group 3: 120 mg FruitexB® twice per day
Group 4: 120 mg placebo twice per day. Placebo material was based on fructose only.

The duration of the treatment was 2 weeks, administered as 2 capsules twice per day (BID) ingested orally with meals. Survey on dietary intake was carried out by personal interview. Interviewers presented tableware and food models and investigated the meal intake on 2 different weekdays and 1 weekend day based on recall method. Nutrient intake was calculated by use of the DietSYS+Plus (version 5.9), dietary analysis program (Block Dietary Data Systems). The DietSYS+Plus database, a software that analyses nutrients, was expanded for the present study to include dietary boron values in foods consumed in Romania. After calculating the intake of nutrients per individual, percentage of the intake was calculated in relation to Dietary Reference Intakes for Romania. Subsequently, boron intake was calculated useing the boron content database of the foods commonly consumed by Romanian urban and rural people. We utilised the analytical B nutrient database that was previously developed for the purpose of estimating B intake.

Intervention type

Drug

Phase

Phase I

Drug names

FruitexB® (calcium fructoborate)

Primary outcome measures

Determination of biochemical parameters. Blood samples for biochemical analyses were taken from fasting venous blood in the morning at the start, and after 2 weeks of treatment. Commercial tubes without anticoagulant were used to collect blood for determination of biochemical parameters. Basic biochemical parameters, lipid profile (total cholesterol, high density lipoprotein [HDL-], low density lipoprotein [LDL-] cholesterol, and inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ERS] and fibrinogen) were analysed in serum by standard biochemical procedures using the Hitachi 911 automatic analyser and kits (Roche, Switzerland). Due to known correlations between selected markers, the following ratios were used for processing the data: CHOL/CRP and HDL/CRP.

Secondary outcome measures

In neurological literature on diabetic peripheral neuropathy, several neuropathic symptoms and signs scales have been developed, such as the Neurological Symptom Score, the extensive Neuropathy Symptom Profile, and the Neurological Disability Score [B]. These physician-based scales are used primarily in diabetic neuropathy trials in order to diagnose the absence or presence of peripheral neuropathy, although the Neurological Symptom Score does not emphasise actual severity of complaints. Furthermore, consensus guidelines have been published on quantitative sensory testing [B], and on standardised measures in diabetic neuropathy [B]. We used said guidelines to determine paresthesias numbness.

These were measured at the first visit in the day when study begun, and the next measure was done after 2 weeks.

Overall trial start date

10/03/2008

Overall trial end date

30/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and non-pregnant women
2. Aged 40 - 85 years
3. Primary OA of at least one knee as demonstrated by a radiological examination carried out within the previous 3 months
4. Body mass index (BMI) less than 28 and greater than 24.4 kg/m^2
5. Elevated blood levels of at least one inflammatory marker

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 patients

Participant exclusion criteria

1. Individuals with digestion problems
2. Subjects with a fever and/or under treatment with antibiotics
3. Subjects with fructose intolerance
4. Subjects taking any painkillers and/or vitamin B6
5. Subjects taking aspirin
6. Current use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetominophen

Recruitment start date

10/03/2008

Recruitment end date

30/08/2009

Locations

Countries of recruitment

Romania

Trial participating centre

a.i.cuza no.13
Craiova
200385
Romania

Sponsor information

Organisation

Natural Research, Ltd (Romania)

Sponsor details

a.i.cuza no.13
Craiova
200285
Romania
+40 (0)251 41 59 60
romulus_ion@yahoo.com

Sponsor type

Industry

Website

http://www.naturalresearch.ro/

Funders

Funder type

Industry

Funder name

Natural Research, Ltd (Romania) - Research Project (ref: 12/2008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Medicine and Pharmacy of Craiova (Romania)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes