Study of Supplement's Antioxidant Properties That Contains Natural Extracts

NCT02837107 | Unknown

• 1 other identifier: HAROKOPIO UNIVERSITY
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (8)

• Change from Baseline of Platelet aggregation against PAF at 4 weeks

  0, 4 weeks

• Change from Baseline of Platelet aggregation against PAF at 8 weeks

  0, 8 weeks

• Change from Baseline of Platelet aggregation at against ADP 4 weeks

  0, 4 weeks

• Change from Baseline of Platelet aggregation against ADP at 8 weeks

  0, 8 weeks

• Change from Baseline of Platelet aggregation against TRAP at 4 weeks

  0, 4 weeks

Study Arms (2)

Supplement

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).

Dietary Supplement: Mind Master

Placebo

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.

Dietary Supplement: Placebo

Interventions

Mind Master DIETARY_SUPPLEMENT

80ml Mind Master / day for 8 weeks

Also known as: Mind Master LR Health & Beauty Systems

Supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• BMI: 23-30

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead

Related Publications (1)

• 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.

  PMID: 30115068 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biological Chemistry

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: July 19, 2016
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2017
• Last Updated: July 20, 2016

Record last verified: 2016-07