Clinical trial NCT02837107: Study of Supplement's Antioxidant Properties That Contains Natural Extracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline of isoprostane levels at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of isoprostane levels at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of DNA/RNA damage at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of DNA/RNA damage at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of protein carbonyls levels at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of protein carbonyls levels at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of oxLDL levels at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of oxLDL levels at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of TBARS levels at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of TBARS levels at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of serum resistant in oxidation at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of serum resistant in oxidation at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of anti-oxidant enzymes activity at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of anti-oxidant enzymes activity at 8 weeks
timeFrame: 0, 8 weeks
Secondary outcomes:
measure: Change from Baseline of Platelet aggregation against PAF at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of Platelet aggregation against PAF at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of Platelet aggregation at against ADP 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of Platelet aggregation against ADP at 8 weeks
timeFrame: 0, 8 weeks
measure: Change from Baseline of Platelet aggregation against TRAP at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of Platelet aggregation against TRAP at 8 weeks
timeFrame: 0,8 weeks
measure: Change from Baseline of Inflammatory markers at 4 weeks
timeFrame: 0, 4 weeks
measure: Change from Baseline of Inflammatory markers at 8 weeks
timeFrame: 0,8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.