Innovative Biotechnological Production of Antioxidant Products
Condition: Oxidative Stress; Inflammation; Body Weight; Homocystine; Metabolic Disorder
MeSH terms: Metabolic Diseases; Inflammation; Body Weight
Study type: Interventional

Summary: 
      Several natural compounds have been explored as immune-boosting, antioxidant, and
      anti-inflammatory dietary supplements. Amongst them, hydroxytyrosol a natural antioxidant
      found in olive products, and endemic medicinal plants have attracted the scientific's
      community and industry's interest. The safety and biological activity of a standardised
      supplement containing 10 mg of hydroxytyrosol synthesized using genetically modified
      Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris,
      sage officinalis and crithmum maritimum in an open-label, single-arm, prospective clinical
      study were studied. The supplement capsules were given to 12 healthy subjects, aged 26-52,
      once a day for 8 weeks.
    

Detailed description: 
      The study was designed to evaluate the safety and biological activity of the supplement
      Antiox-Plus: one capsule/day, 15 minutes before their main meal which contained 10 mg of HT,
      synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL)
      of essential oils from Origanum vulgare, Sage officinalis and Crithmum maritimum. The
      volunteers will consume the supplement for 8 weeks. A follow-up analysis will be performed
      one month after the end of the supplementation period (12 weeks from the initiation of the
      study). During this time, the participants will consume a placebo.

      The volunteers are instructed to maintain their normal dietary habits. The following
      measurements will be taken: A) Dietary assessment at the beginning of the study (week 0), B)
      Body composition analysis at the beginning (week 0) and the end of the study (week 8), C)
      biochemical and laboratory analysis of plasma samples at week 0, 8 and 12.

      The volunteers will record their food intake for 3 days (including one day of the weekend)
      and will fulfil a food frequency questionnaire. Analysis of their data will be done by a
      certified nutritionist. Nutritional assessment will be performed using the Evexis dietary
      software. The Tanita Dual Frequency Body Composition Monitor "Innerscan" will be employed to
      measure weight, muscle mass, muscle quality score, heart rate, body fat (%), physique rating,
      visceral fat, metabolic age, basal metabolic rate, bone mass, body water (%) and body mass
      index (BMI) in the morning. Physical activity will be assessed by the Greek version of the
      short International Physical Activity Questionnaire (IPAQ-short).
    

Intervention name(s): Hydroxytyrosol/Essential oils
Intervention type(s): Dietary Supplement
Intervention description(s): A dietary supplement containing 10 mg of hydroxytyrosol, synthesised using genetically modified Escherichia coli strains and equal amounts (8.33 μL) of essential oils from oregano vulgaris, sage officinalis and crithmum maritimum.
Intervention MeSH terms: 3,4-dihydroxyphenylethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention