Condition category
Mental and Behavioural Disorders
Date applied
24/02/2015
Date assigned
26/02/2015
Last edited
02/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
karakitsosdimitrios@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dimitrios Karakitsos

ORCID ID

Contact details

3 Ithakis Street
Pallini
Athens
15351
Greece
0030-6947127965
karakitsosdimitrios@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZSB/CA-2015-1

Study information

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.

Acronym

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

General state hospital of Athens- ZSB/2014, ref: 1089

Study design

Prospective, randomized case control study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2014

Overall trial end date

01/03/2015

Reason abandoned

Eligibility

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 type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

50

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

Trial participating centre

General State Hospital of Athens
154 Mesogeion Avenue
Athens
11527
Greece

Trial participating centre

Laiko Hospital
Agiou Thoma 17
Athens
11527
Greece

Sponsor information

Organisation

Medicines from Earth LTD

Sponsor details

Saborna 4 Entr B
Sofia
1000
Bulgaria
+30-6944645533
info@medfromearth.com

Sponsor type

Industry

Website

www.medfromearth.com

Funders

Funder type

Industry

Funder name

Medicines from Earth LTD (Bulgaria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/03/2014

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes