Study of Supplement's Antioxidant Properties That Contains Natural Extracts

Healthy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02837107
• Other study ID #: HAROKOPIO UNIVERSITY
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2016
• Last updated: July 19, 2016
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: December 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mind Master
80ml Mind Master / day for 8 weeks
• Placebo
80ml a look-alike Placebo / day for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of isoprostane levels at 4 weeks	urinary isoprostane	0, 4 weeks	No
Primary	Change from Baseline of isoprostane levels at 8 weeks	urinary isoprostane	0, 8 weeks	No
Primary	Change from Baseline of DNA/RNA damage at 4 weeks	urinary DNA/RNA damage	0, 4 weeks	No
Primary	Change from Baseline of DNA/RNA damage at 8 weeks	urinary DNA/RNA damage	0, 8 weeks	No
Primary	Change from Baseline of protein carbonyls levels at 4 weeks	serum	0, 4 weeks	No
Primary	Change from Baseline of protein carbonyls levels at 8 weeks	serum	0, 8 weeks	No
Primary	Change from Baseline of oxLDL levels at 4 weeks	serum	0, 4 weeks	No
Primary	Change from Baseline of oxLDL levels at 8 weeks	serum	0, 8 weeks	No
Primary	Change from Baseline of TBARS levels at 4 weeks	serum	0, 4 weeks	No
Primary	Change from Baseline of TBARS levels at 8 weeks	serum	0, 8 weeks	No
Primary	Change from Baseline of serum resistant in oxidation at 4 weeks	ex vivo serum oxidation with cupper	0, 4 weeks	No
Primary	Change from Baseline of serum resistant in oxidation at 8 weeks	ex vivo serum oxidation with cupper	0, 8 weeks	No
Primary	Change from Baseline of anti-oxidant enzymes activity at 4 weeks	serum	0, 4 weeks	No
Primary	Change from Baseline of anti-oxidant enzymes activity at 8 weeks	serum	0, 8 weeks	No
Secondary	Change from Baseline of Platelet aggregation against PAF at 4 weeks	PRP aggregation against PAF	0, 4 weeks	No
Secondary	Change from Baseline of Platelet aggregation against PAF at 8 weeks	PRP aggregation against PAF	0, 8 weeks	No
Secondary	Change from Baseline of Platelet aggregation at against ADP 4 weeks	PRP aggregation against ADP	0, 4 weeks	No
Secondary	Change from Baseline of Platelet aggregation against ADP at 8 weeks	PRP aggregation against ADP	0, 8 weeks	No
Secondary	Change from Baseline of Platelet aggregation against TRAP at 4 weeks	PRP aggregation against TRAP	0, 4 weeks	No
Secondary	Change from Baseline of Platelet aggregation against TRAP at 8 weeks	PRP aggregation against TRAP	0,8 weeks	No
Secondary	Change from Baseline of Inflammatory markers at 4 weeks	serum LpPLA2 activity	0, 4 weeks	No
Secondary	Change from Baseline of Inflammatory markers at 8 weeks	serum LpPLA2 activity	0,8 weeks	No