Study of Supplement's Antioxidant Properties That Contains Natural Extracts

• ClinicalTrials.gov Identifier: NCT02837107
• Recruitment Status: Unknown
• First Posted: July 19, 2016
• Last Update Posted: July 20, 2016
• Sponsor: Harokopio University
• Information provided by (Responsible Party): Elizabeth Fragopoulou, Harokopio University

Tracking Information

• First Submitted Date: May 23, 2016
• First Posted Date: July 19, 2016
• Last Update Posted Date: July 20, 2016
• Study Start Date: September 2013
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Supplement's Antioxidant Properties That Contains Natural Extracts
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Healthy

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 14, 2016): 62
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02837107
• Other Study ID Numbers: HAROKOPIO UNIVERSITY
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elizabeth Fragopoulou, Harokopio University
• Study Sponsor: Harokopio University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Harokopio University
• Verification Date: July 2016