Overview

This trial is active, not recruiting.

Condition healthy
Treatments mind master, placebo
Sponsor Harokopio University
Start date September 2013
End date October 2014
Trial size 62 participants
Trial identifier NCT02837107, HAROKOPIO UNIVERSITY

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
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).
mind master Mind Master LR Health & Beauty Systems
80ml Mind Master / day for 8 weeks
(Placebo Comparator)
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.
placebo
80ml a look-alike Placebo / day for 8 weeks

Primary Outcomes

Measure
Change from Baseline of isoprostane levels at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of isoprostane levels at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of DNA/RNA damage at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of DNA/RNA damage at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of protein carbonyls levels at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of protein carbonyls levels at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of oxLDL levels at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of oxLDL levels at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of TBARS levels at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of TBARS levels at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of serum resistant in oxidation at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of serum resistant in oxidation at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of anti-oxidant enzymes activity at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of anti-oxidant enzymes activity at 8 weeks
time frame: 0, 8 weeks

Secondary Outcomes

Measure
Change from Baseline of Platelet aggregation against PAF at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of Platelet aggregation against PAF at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of Platelet aggregation at against ADP 4 weeks
time frame: 0, 4 weeks
Change from Baseline of Platelet aggregation against ADP at 8 weeks
time frame: 0, 8 weeks
Change from Baseline of Platelet aggregation against TRAP at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of Platelet aggregation against TRAP at 8 weeks
time frame: 0,8 weeks
Change from Baseline of Inflammatory markers at 4 weeks
time frame: 0, 4 weeks
Change from Baseline of Inflammatory markers at 8 weeks
time frame: 0,8 weeks

Eligibility Criteria

Male or female participants from 25 years up to 40 years old.

Inclusion Criteria: healthy BMI: 23-30 Exclusion Criteria: regular use of dietary supplements or medications being on slimming or any other special diet athlete hypertension metabolic or endocrine disease gastrointestinal disorders a recent history of medical or surgical events

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Harokopio University.