Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Supplement's Antioxidant Properties That Contains Natural Extracts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date July 20, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Change from Baseline of isoprostane levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    urinary isoprostane
  • Change from Baseline of isoprostane levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    urinary isoprostane
  • Change from Baseline of DNA/RNA damage at 4 weeks [ Time Frame: 0, 4 weeks ]
    urinary DNA/RNA damage
  • Change from Baseline of DNA/RNA damage at 8 weeks [ Time Frame: 0, 8 weeks ]
    urinary DNA/RNA damage
  • Change from Baseline of protein carbonyls levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum
  • Change from Baseline of protein carbonyls levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum
  • Change from Baseline of oxLDL levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum
  • Change from Baseline of oxLDL levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum
  • Change from Baseline of TBARS levels at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum
  • Change from Baseline of TBARS levels at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum
  • Change from Baseline of serum resistant in oxidation at 4 weeks [ Time Frame: 0, 4 weeks ]
    ex vivo serum oxidation with cupper
  • Change from Baseline of serum resistant in oxidation at 8 weeks [ Time Frame: 0, 8 weeks ]
    ex vivo serum oxidation with cupper
  • Change from Baseline of anti-oxidant enzymes activity at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum
  • Change from Baseline of anti-oxidant enzymes activity at 8 weeks [ Time Frame: 0, 8 weeks ]
    serum
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Change from Baseline of Platelet aggregation against PAF at 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against PAF
  • Change from Baseline of Platelet aggregation against PAF at 8 weeks [ Time Frame: 0, 8 weeks ]
    PRP aggregation against PAF
  • Change from Baseline of Platelet aggregation at against ADP 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against ADP
  • Change from Baseline of Platelet aggregation against ADP at 8 weeks [ Time Frame: 0, 8 weeks ]
    PRP aggregation against ADP
  • Change from Baseline of Platelet aggregation against TRAP at 4 weeks [ Time Frame: 0, 4 weeks ]
    PRP aggregation against TRAP
  • Change from Baseline of Platelet aggregation against TRAP at 8 weeks [ Time Frame: 0,8 weeks ]
    PRP aggregation against TRAP
  • Change from Baseline of Inflammatory markers at 4 weeks [ Time Frame: 0, 4 weeks ]
    serum LpPLA2 activity
  • Change from Baseline of Inflammatory markers at 8 weeks [ Time Frame: 0,8 weeks ]
    serum LpPLA2 activity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Supplement's Antioxidant Properties That Contains Natural Extracts
Official Title  ICMJE Not Provided
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Mind Master
    80ml Mind Master / day for 8 weeks
    Other Name: Mind Master LR Health & Beauty Systems
  • Dietary Supplement: Placebo
    80ml a look-alike Placebo / day for 8 weeks
Study Arms  ICMJE
  • 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).
    Intervention: Dietary Supplement: Mind Master
  • 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.
    Intervention: Dietary Supplement: Placebo
Publications * Fragopoulou E, Gavriil L, Argyrou C, Malagaris I, Choleva M, Antonopoulou S, Afxentiou G, Nikolaou E. Suppression of DNA/RNA and protein oxidation by dietary supplement which contains plant extracts and vitamins: a randomized, double-blind, placebo-controlled trial. Lipids Health Dis. 2018 Aug 16;17(1):187. doi: 10.1186/s12944-018-0836-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
62
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02837107
Other Study ID Numbers  ICMJE HAROKOPIO UNIVERSITY
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Fragopoulou, Harokopio University
Study Sponsor  ICMJE Harokopio University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Harokopio University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP