Potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers with stressful life styles
| ISRCTN | ISRCTN11812295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11812295 |
| Secondary identifying numbers | ZSB/CA-2015-1 |
- Submission date
- 24/02/2015
- Registration date
- 26/02/2015
- Last edited
- 04/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Zeolites are unique, natural volcanic minerals. They have antioxidant and antiviral properties and act as natural “magnets” that absorb and remove toxins, such as heavy metals, chemicals and pollutants from the body. Sea Buckthorn oil is a herb rich in antioxidants (due primarily to its high flavonoid and vitamin C content), essential amino acids and omega 7. Studies have shown it to lower cholesterol and improve heart function in people with coronary heart disease. The aim of this study is to examine the potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers with stressful life styles.
Who can participate?
Healthy Caucasion adults that smoke, consume a unhealthy diet, have stressful office jobs and physically inactive.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group A (control group) are given a placebo three times a day for 3 months. Those in group B (study group) are given the ZSB dietary supplement (600 mg of natural clinoptilolite zeolite and 150 of sea buckthorn, three times a day for 3 months). Blood samples are taken before start of the study and at the end. Participants are also followed up on regular intervals (every 15 days) during the study period.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
General State Hospital of Athens and Laiko Hospital, Athens (Greece)
When is the study starting and how long is it expected to run for?
January 2014 to March 2015
Who is funding the study?
Medicines from Earth LTD (Bulgaria)
Who is the main contact?
Dr Dimitrios Karakitsos
jkd97227@gmail.com
Contact information
Scientific
3 Ithakis Street
Pallini
Athens
15351
Greece
| Phone | 0030-6947127965 |
|---|---|
| jkd97227@gmail.com |
Study information
| Study design | Prospective, randomized case control study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers with stressful life styles: a prospective, randomized case control study. |
| Study hypothesis | We examined the potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers who were consuming non-healthy food and exhibited a stressful life style. |
| Ethics approval(s) | General state hospital of Athens- ZSB/2014, ref: 1089 |
| Condition | We have examined the antioxidant status of healthy volunteers who were smokers, followed an unhealthy diet as defined by the consumption of junk food at least 3 times per week and were doing stressful (office) jobs. The subjects reported also minimal levels of physical exercise as defined by walking less than one mile per day. |
| Intervention | Upon inclusion, patients were randomized to Group A (controls, 25 subjects) who were receiving a placebo and Group B (study group, 25 subjects) who were receiving the ZSB dietary supplement (600 mg of natural clinoptilolite zeolite and 150 of sea buckthorn, three times/day). Block randomization was performed to ensure equal number of patients in the two groups. |
| Intervention type | Supplement |
| Primary outcome measure | To evaluate the anti-oxidant properties of ZSB by measuring the total antioxidant status (TAS) and the thiobarbituric acid reactive substances (TBARS) test in cases and controls. |
| Secondary outcome measures | 1. Any potential side effects following the administration of ZSB. Patients were followed every 15 days by means of total blood counts and regular biochemical studies including urea, creatinine, and hepatic enzymes 2. Patient self-evaluation (via a questionnaire) of any potential changes in their smoking/dietary habits, level of physical activity (walking miles per day) and stress levels. Stress levels were assessed by means of a semi-quantitative scale (1 to 10; whereas 1 indicated no stress and 10 high stress levels). |
| Overall study start date | 01/01/2014 |
| Overall study end date | 01/03/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Healthy Caucasian volunteers (20 males, 37 ± 6.3 year old, with body mass index (BMI) 28.2 ± 1.6) who were following a non-healthy type of diet as defined by the consumption of junk food at least 3 times on a weekly basis were recruited from a relatively young population of patients who have been visiting during 2014 an outpatient medical clinic of a university hospital for routine check-up purposes 2. All patients were smokers (15 packs. yr ± 2.7) 3. All were doing stressful (office) jobs 4. Level of physical exercise was minimal as defined by walking less than a mile/day 5. All patients provided formal informed consent to participate in the study which was approved by the institutional ethics committee |
| Participant exclusion criteria | 1. Any recorded active medical disorder 2. History of cardiovascular disease or any other systemic inflammatory disorder 3. Abnormal lipid blood profiles 4. Age over 65 years old |
| Recruitment start date | 01/01/2014 |
| Recruitment end date | 01/01/2015 |
Locations
Countries of recruitment
- Greece
Study participating centres
Athens
11527
Greece
Athens
11527
Greece
Sponsor information
Industry
Saborna 4 Entr B
Sofia
1000
Bulgaria
| Phone | +30-6944645533 |
|---|---|
| info@medfromearth.com | |
| Website | www.medfromearth.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2014 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study will soon be over and we are ready to publish our preliminary results by next month in an indexed open access medical journal. |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
04/05/2022: The study contact has been updated and the plain English summary has been updated accordingly.
11/09/2019: No publications found, verifying study status with principal investigator.
