Effects of calcium fructoborate on markers of subclinical atherosclerosis
| ISRCTN | ISRCTN90543844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90543844 |
| Secondary identifying numbers | Research Project no.14/2012 |
- Submission date
- 08/05/2012
- Registration date
- 24/05/2012
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Natural Research Ltd
Bioboron Research Institute
AI Cuza street no.15 Bloc Patria ap.11
Craiova
200386
Romania
| Phone | +40 744 538 207 |
|---|---|
| romulusscorei@gmail.com |
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of calcium fructoborate alone on markers of subclinical atherosclerosis in a healthy population |
| Study objectives | 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(s) | Institutional Ethics Committee of the University of Medicine and Pharmacy from Craiova, Romania, 03/05/2012, ref: 431 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 30/06/2012 |
| Completion date | 30/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/06/2012 |
| Date of final enrolment | 30/12/2012 |
Locations
Countries of recruitment
- Romania
Study participating centre
200386
Romania
Sponsor information
Industry
Bioboron Research Institute
AI Cuza no.15 Bloc Patria Sc.1 ap.11
Craiova
200398
Romania
| Phone | +40 744 538 207 |
|---|---|
| romulusscorei@gmail.com | |
| Website | http://www.naturalresearch.ro |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
