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Trial record 3 of 6 for:    coq10 AND dementia

Study of Supplement's Antioxidant Properties That Contains Natural Extracts

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Fragopoulou, Harokopio University
ClinicalTrials.gov Identifier:
NCT02837107
First received: May 23, 2016
Last updated: July 19, 2016
Last verified: July 2016
  Purpose

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 Intervention
Healthy
Dietary Supplement: Mind Master
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Harokopio University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 62
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Elizabeth Fragopoulou, Assistant Professor of Biological Chemistry, Harokopio University
ClinicalTrials.gov Identifier: NCT02837107     History of Changes
Other Study ID Numbers: HAROKOPIO UNIVERSITY
Study First Received: May 23, 2016
Last Updated: July 19, 2016

ClinicalTrials.gov processed this record on March 24, 2017