Study of Supplement's Antioxidant Properties That Contains Natural Extracts

Study Overview
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Brief Summary
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While it is well accepted that a low level of RONS production is necessary to maintain physiological function, too much formation of RONS are believed to participate in biomolecules damage. Damage of lipids, proteins and DNA/RNA, to cellular and tissue level, as a consequence of oxidative stress has been linked to a number of serious diseases, including cancer, cardiovascular diseases (CVDs) such as hypertension and atherosclerosis, neurodegenerative diseases such as Parkinson's disease and Alzheimer's dementias, diabetes and the process of aging. The dietary intake of antioxidants is thought to play a major role in oxidative stress network. Many epidemiologic studies have reported an inverse association between vegetable and fruit consumption with reduced risk of chronic diseases, especially cancer and CVDs. However, although many clinical trials have been conducted with vitamins (E, C or their combinations) their in vivo protective effect remains uncertain. Therefore the possibility that the complex mixture of phytochemicals in foods may contribute to their protecting effects has been raised. In this concept, it is possible multiple compounds to act through complimentary or synergistic mechanisms to present a greater biologic effect than can be achieved by any individual component To investigate this hypothesis, a double-blind, randomized, and placebo-controlled clinical trial was conducted in order to investigate the effects of a multi-micronutrient supplement against oxidative stress in apparently healthy adults.

Detailed Description
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This was a double-blind, block randomized, parallel-arm, placebo-controlled, eight-week study. Initially 77 apparently healthy volunteers were recruited to participate in the study. 62 volunteers were enrolled in the study and assigned to either the MM group (n = 32) or the placebo group (n = 30) using a stratified randomization to guarantee comparability of age, sex and BMI distribution between the two groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. At the initiation of the study, the subjects received 5 bottles (0.5L each) of the MM or placebo, which were made indistinguishable by their identical packaging. At 4 weeks the subjects received again 5 bottles. The subjects were asked to consume 80mL per day, preferably after meals. The dose was chosen based on the commercially recommended level. At each visit, the remaining volume of the supplement was counted by research coordinators. The subjects were excluded from the analysis if they consumed <80% of the recommended dose.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Mind Master
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy BMI: 23-30 Exclusion Criteria: regular use of dietary supplements or medications being on slimming or any other special diet hypertension metabolic or endocrine disease gastrointestinal disorders recent history of medical or surgical events

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement<br>The supplement (Mind Master) were custom prepared and donated by LR Healthy and Beauty Systems LTD. The supplement contained per 80ml, aloe barbadensis miller gel (USA/Mexico 36%), grape juice, Polygonum cuspidatum extract (that contain 10% resveratrol), green tea extract, 1.1 mg vitamin B1 (100% RDA), 2.5 µg vitamin B12 (100% RDA), 12 mg vitamin E (α - ΤΕ) (100% RDA), coenzyme Q10, 200 µg folic acid (100% RDA), ascorbic acid, 27.5 µg selenium (100% RDA), 4.2 mg iron (100% RDA). | Dietary Supplement: Mind Master<br>* 80ml Mind Master / day for 8 weeks<br>* Other names: Mind Master LR Health & Beauty Systems;|
| Placebo Comparator: Placebo<br>A look-alike placebo were prepared and donated by LR Healthy and Beauty Systems LTD. The placebo contained Aloe barbadensis Miller Gel (USA/Mexico 3.6%), ascorbic acid, and some excipients. | Dietary Supplement: Placebo<br>* 80ml a look-alike Placebo / day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of isoprostane levels at 4 weeks | urinary isoprostane | 0, 4 weeks | 
| Change from Baseline of isoprostane levels at 8 weeks | urinary isoprostane | 0, 8 weeks | 
| Change from Baseline of DNA/RNA damage at 4 weeks | urinary DNA/RNA damage | 0, 4 weeks | 
| Change from Baseline of DNA/RNA damage at 8 weeks | urinary DNA/RNA damage | 0, 8 weeks | 
| Change from Baseline of protein carbonyls levels at 4 weeks | serum | 0, 4 weeks | 
| Change from Baseline of protein carbonyls levels at 8 weeks | serum | 0, 8 weeks | 
| Change from Baseline of oxLDL levels at 4 weeks | serum | 0, 4 weeks | 
| Change from Baseline of oxLDL levels at 8 weeks | serum | 0, 8 weeks | 
| Change from Baseline of TBARS levels at 4 weeks | serum | 0, 4 weeks | 
| Change from Baseline of TBARS levels at 8 weeks | serum | 0, 8 weeks | 
| Change from Baseline of serum resistant in oxidation at 4 weeks | ex vivo serum oxidation with cupper | 0, 4 weeks | 
| Change from Baseline of serum resistant in oxidation at 8 weeks | ex vivo serum oxidation with cupper | 0, 8 weeks | 
| Change from Baseline of anti-oxidant enzymes activity at 4 weeks | serum | 0, 4 weeks | 
| Change from Baseline of anti-oxidant enzymes activity at 8 weeks | serum | 0, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Platelet aggregation against PAF at 4 weeks | PRP aggregation against PAF | 0, 4 weeks | 
| Change from Baseline of Platelet aggregation against PAF at 8 weeks | PRP aggregation against PAF | 0, 8 weeks | 
| Change from Baseline of Platelet aggregation at against ADP 4 weeks | PRP aggregation against ADP | 0, 4 weeks | 
| Change from Baseline of Platelet aggregation against ADP at 8 weeks | PRP aggregation against ADP | 0, 8 weeks | 
| Change from Baseline of Platelet aggregation against TRAP at 4 weeks | PRP aggregation against TRAP | 0, 4 weeks | 
| Change from Baseline of Platelet aggregation against TRAP at 8 weeks | PRP aggregation against TRAP | 0,8 weeks | 
| Change from Baseline of Inflammatory markers at 4 weeks | serum LpPLA2 activity | 0, 4 weeks | 
| Change from Baseline of Inflammatory markers at 8 weeks | serum LpPLA2 activity | 0,8 weeks |