ISRCTN - ISRCTN90543844: Effects of calcium fructoborate on markers of subclinical atherosclerosis

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
romulusscorei@gmail.com

Trial website

http://www.naturalresearch.ro

Contact information

Type

Scientific

Primary contact

Prof Romulus Scorei

ORCID ID

Contact details

Natural Research Ltd
Bioboron Research Institute
AI Cuza street no.15 Bloc Patria ap.11
Craiova
200386
Romania
+40 744 538 207
romulusscorei@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

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

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

Subclinical atherosclerosis in a healthy population

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measure

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

30/06/2012

Overall trial end date

30/12/2012

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

30/06/2012

Recruitment end date

30/12/2012

Locations

Countries of recruitment

Romania

Trial participating centre

Natural Research Ltd
Craiova
200386
Romania

Sponsor information

Organisation

Natural Research Ltd (Romania)

Sponsor details

Bioboron Research Institute
AI Cuza no.15 Bloc Patria Sc.1 ap.11
Craiova
200398
Romania
+40 744 538 207
romulusscorei@gmail.com