Study of Supplement's Antioxidant Properties That Contains Natural Extracts

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Mind Master; Dietary supplement: Placebo

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
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Harokopio University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HAROKOPIO UNIVERSITY