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Study of Supplement's Antioxidant Properties That Contains Natural Extracts

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ClinicalTrials.gov Identifier: NCT02837107
Recruitment Status : Unknown
Verified July 2016 by Elizabeth Fragopoulou, Harokopio University.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth Fragopoulou, Harokopio University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Mind Master Dietary Supplement: Placebo Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Supplement
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
80ml Mind Master / day for 8 weeks
Other Name: Mind Master LR Health & Beauty Systems
Placebo Comparator: Placebo
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
80ml a look-alike Placebo / day for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline of isoprostane levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    urinary isoprostane

  2. Change from Baseline of isoprostane levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    urinary isoprostane

  3. Change from Baseline of DNA/RNA damage at 4 weeks [ Time Frame: 0, 4 weeks ]
    urinary DNA/RNA damage

  4. Change from Baseline of DNA/RNA damage at 8 weeks [ Time Frame: 0, 8 weeks ]
    urinary DNA/RNA damage

  5. Change from Baseline of protein carbonyls levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum

  6. Change from Baseline of protein carbonyls levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum

  7. Change from Baseline of oxLDL levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum

  8. Change from Baseline of oxLDL levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum

  9. Change from Baseline of TBARS levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum

  10. Change from Baseline of TBARS levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum

  11. Change from Baseline of serum resistant in oxidation at 4 weeks [ Time Frame: 0, 4 weeks ]
    ex vivo serum oxidation with cupper

  12. Change from Baseline of serum resistant in oxidation at 8 weeks [ Time Frame: 0, 8 weeks ]
    ex vivo serum oxidation with cupper

  13. Change from Baseline of anti-oxidant enzymes activity at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum

  14. Change from Baseline of anti-oxidant enzymes activity at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum


Secondary Outcome Measures :
  1. Change from Baseline of Platelet aggregation against PAF at 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against PAF

  2. Change from Baseline of Platelet aggregation against PAF at 8 weeks [ Time Frame: 0, 8 weeks ]
    PRP aggregation against PAF

  3. Change from Baseline of Platelet aggregation at against ADP 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against ADP

  4. Change from Baseline of Platelet aggregation against ADP at 8 weeks [ Time Frame: 0, 8 weeks ]
    PRP aggregation against ADP

  5. Change from Baseline of Platelet aggregation against TRAP at 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against TRAP

  6. Change from Baseline of Platelet aggregation against TRAP at 8 weeks [ Time Frame: 0,8 weeks ]
    PRP aggregation against TRAP

  7. Change from Baseline of Inflammatory markers at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum LpPLA2 activity

  8. Change from Baseline of Inflammatory markers at 8 weeks [ Time Frame: 0,8 weeks ]
    serum LpPLA2 activity


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Elizabeth Fragopoulou, Assistant Professor of Biological Chemistry, Harokopio University
ClinicalTrials.gov Identifier: NCT02837107    
Other Study ID Numbers: HAROKOPIO UNIVERSITY
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016