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
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 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
30/06/2012
Overall trial end date
30/12/2012
Reason abandoned
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
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Natural Research Ltd (Romania), ref: 14/2012
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Medicine and Pharmacy, 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