Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous clinical studies have shown the anti-inflammatory and antioxidant characteristics of calcium fructoborate and suggest that this compound supports cardiovascular (heart) health. In particular, calcium fructoborate has been shown to lower CRP in patients with symptoms of osteoarthritis and stable angina pectoris. Further research suggests calcium fructoborate may lower blood levels of LDL-cholesterol and raise blood levels of HDL-cholesterol. The aim of our study is to assess the effects of FruiteX-B® Calcium Fructoborate on markers of subclinical atherosclerosis in a healthy population.

Who can participate?
This trial will include healthy men and women, age 40-60.

What does the study involve?
The study will take 30 days and participants will be randomly divided into two groups: one group will receive FruiteX-B® Calcium Fructoborate and the other group will be given a placebo (dummy drug). At the end of the study, we will compare the results of the blood clinical laboratory tests between the groups of participants.

What are the possible benefits and risks of participating?
The immediate benefit may be the reduction of inflammation and lipid markers. In the long term, the participants’ quality of life may be improved. There are no known risks of the study.

Where is the study run from?
Natural Research, Ltd. and the University of Medicine and Pharmacy, Craiova, Romania.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start mid 2012 and the trial will last for about 6 months.

Who is funding the study?
Natural Research, Ltd. and the University of Medicine and Pharmacy, Craiova, Romania.

Who is the main contact?
Prof Romulus Scorei

Trial website

Contact information



Primary contact

Prof Romulus Scorei


Contact details

Natural Research Ltd
Bioboron Research Institute
AI Cuza street no.15 Bloc Patria ap.11
+40 744 538 207

Additional identifiers

EudraCT number number

Protocol/serial number

Research Project no.14/2012

Study information

Scientific title

Effects of calcium fructoborate alone on markers of subclinical atherosclerosis in a healthy population


Study hypothesis

The purpose of this study is to assess the effects of FruiteX-B® Calcium Fructoborate alone on markers of subclinical atherosclerosis in a healthy population.

Ethics approval

Institutional Ethics Committee of the University of Medicine and Pharmacy from Craiova, Romania, 03/05/2012, ref: 431

Study design

Randomised double-blind placebo-controlled single-centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Subclinical atherosclerosis in a healthy population


Clinical study of FruitexB-X® mg versus placebo.
Study duration: 30 days, two doses per day.
Four time points: day 1, 4, 7, and 30
Placebo-controlled, double-blind study
Placebo material: 103 mg of fructose (the amount of fructose equivalent to what would be present in a 112 mg serving of FruiteX-B)

Intervention type



Not Applicable

Drug names

Primary outcome measures

Blood clinical laboratory tests:
1. Fasting plasma glucose
2. Total, LDL and HDL cholesterol, triglycerides
3. High-sensitivity C-reactive protein (hs-CRP)
4. Metallic metalloproteinase-9 (MMP-9)
5. Monocyte chemotactic protein 1 (MCP-1)
6. Lipoprotein-associated phospholipase A(2) (Lp-PLA(2))
7. IL-6
8. Homocysteine
9. oxLDL
10. Vitamin D3 (Calcidiol)
11. Adiponectin
12. Insulin
13. PON-1
14. Isoprostanes

Secondary outcome measures

1. Clinical exam
2. 12-lead ECG
3. Ankle-brachial index

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male or female patients aged 40-60
2. Gender ratio: 50% females and 50% males
3. BMI range: 24-27 (overweight but not obese)
4. Normal or minor hypertension (<140/80-90)
5. Increased level of blood CRP (>3 mg/l)
6. Increased LDL (>130)
7. Increased triglyceride level (>200)
8. Reduced HDL level (<40)
9. Fasted glucose level (<100)
10. Informed consent obtained at selection

Participant type


Age group




Target number of participants

150 healthy subjects; 100 on active therapy (FruiteX-B® at two separate daily serving sizes: 56 mg (28 mg twice daily) and 112 mg (56 mg twice daily), 50 on placebo

Participant exclusion criteria

Subjects with nonphysiological and pathological conditions such as:
1. Cardiovascular (CV) symptoms (e.g., angina, shortness of breath, etc)
2. CV disease
3. Diabetes mellitus or renal failure
4. Infectious or inflammatory disease
5. Active allergy
6. Smokers
7. Subjects who consume more than two alcoholic beverages per day
8. Subjects using any supplements 30 days prior to the initiation of the study
9. Subjects using statins, anti-hypertensive, anti-hyperlipidemia, anti-inflammatory, or anti-diabetic medications

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Natural Research Ltd

Sponsor information


Natural Research Ltd (Romania)

Sponsor details

Bioboron Research Institute
AI Cuza no.15 Bloc Patria Sc.1 ap.11
+40 744 538 207

Sponsor type




Funder type


Funder name

Natural Research Ltd (Romania), ref: 14/2012

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

University of Medicine and Pharmacy, Craiova (Romania)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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