Potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers with stressful life styles

• Register: ISRCTN
• Last refreshed on: 16 May 2022
• Main ID: ISRCTN11812295
• Date of registration: 26/02/2015
• Prospective Registration: No
• Primary sponsor: Medicines from Earth LTD
• Public title: Potential antioxidant effects of a natural clinoptilolite zeolite/sea buckthorn (ZSB) dietary supplement on smokers with stressful life styles
• 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.
• Date of first enrolment: 01/01/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11812295
• Study type: Interventional
• Study design: Prospective, randomized case control study. (Treatment)
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Dimitrios Karakitsos

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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.
Mental and Behavioural Disorders

Intervention(s)

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.

Primary Outcome(s)

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(s)

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).

Secondary ID(s)

ZSB/CA-2015-1

Source(s) of Monetary Support

Medicines from Earth LTD (Bulgaria)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/03/2015