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Study of Supplement's Antioxidant Properties That Contains Natural Extracts

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837107
Enrollment
62
Registered
2016-07-19
Start date
2013-09-30
Completion date
2017-12-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTMind Master

80ml Mind Master / day for 8 weeks

DIETARY_SUPPLEMENTPlacebo

80ml a look-alike Placebo / day for 8 weeks

Sponsors

Harokopio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline of anti-oxidant enzymes activity at 8 weeks0, 8 weeksserum
Change from Baseline of protein carbonyls levels at 8 weeks0, 8 weeksserum
Change from Baseline of oxLDL levels at 4 weeks0, 4 weeksserum
Change from Baseline of oxLDL levels at 8 weeks0, 8 weeksserum
Change from Baseline of TBARS levels at 4 weeks0, 4 weeksserum
Change from Baseline of TBARS levels at 8 weeks0, 8 weeksserum
Change from Baseline of serum resistant in oxidation at 4 weeks0, 4 weeksex vivo serum oxidation with cupper
Change from Baseline of serum resistant in oxidation at 8 weeks0, 8 weeksex vivo serum oxidation with cupper
Change from Baseline of anti-oxidant enzymes activity at 4 weeks0, 4 weeksserum
Change from Baseline of isoprostane levels at 4 weeks0, 4 weeksurinary isoprostane
Change from Baseline of isoprostane levels at 8 weeks0, 8 weeksurinary isoprostane
Change from Baseline of DNA/RNA damage at 4 weeks0, 4 weeksurinary DNA/RNA damage
Change from Baseline of DNA/RNA damage at 8 weeks0, 8 weeksurinary DNA/RNA damage
Change from Baseline of protein carbonyls levels at 4 weeks0, 4 weeksserum

Secondary

MeasureTime frameDescription
Change from Baseline of Platelet aggregation against PAF at 8 weeks0, 8 weeksPRP aggregation against PAF
Change from Baseline of Platelet aggregation at against ADP 4 weeks0, 4 weeksPRP aggregation against ADP
Change from Baseline of Platelet aggregation against ADP at 8 weeks0, 8 weeksPRP aggregation against ADP
Change from Baseline of Platelet aggregation against TRAP at 4 weeks0, 4 weeksPRP aggregation against TRAP
Change from Baseline of Platelet aggregation against TRAP at 8 weeks0,8 weeksPRP aggregation against TRAP
Change from Baseline of Inflammatory markers at 4 weeks0, 4 weeksserum LpPLA2 activity
Change from Baseline of Inflammatory markers at 8 weeks0,8 weeksserum LpPLA2 activity
Change from Baseline of Platelet aggregation against PAF at 4 weeks0, 4 weeksPRP aggregation against PAF

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026