Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
Condition: Body Weight; Visceral Obesity
MeSH terms: Overweight; Obesity, Abdominal; Body Weight
Study type: Interventional

Summary: 
      This study aims to investigate the potential effects of the administration of hydroxytyrosol,
      which is an extra virgin olive oil phenolic compound, in doses 15 milligrams and 5 milligrams
      daily versus placebo for 6 months in anthropometric parameters such as body weight, body fat
      and visceral fat, in combination with diet, in overweight and obese women.
    

Detailed description: 
      Hydroxytyrosol is an extra virgin olive oil phenolic compound which has known protective
      effects in LDL oxidation and reduces oxidative stress. Olive oil has been associated with
      enhanced weight loss, and hydroxytyrosol could have a potential role in this.

      Participants entered the study after signing the informed consent document. Detailed medical
      and family history was taken at baseline visit, and measurement of height, body weight, body
      fat and visceral fat were also made. Each participant visited a dietitian the same day and
      written consultation concerning the diet to be followed was given, based on Mediterranean
      diet and 500 kilocalories below their estimated Basal Metabolic Rate. The above measurements
      and dietitian consultation were repeated in each visit during the intervention (4,12 and 24
      weeks).

      Baseline laboratory testing was made including urea, creatinine, aminotransferases and
      fasting lipids and glucose, while serum and plasma were stored in -80 Celsius degrees for
      future analyses. Blood samples were also taken at 4, 12 and 24 weeks of the intervention.

      All participants had an identical meal test at baseline, at 12 and 24 months and blood
      samples were collected at times 0, 30, 60, 90, 120, 150 and 180 minutes after meal
      consumption. Samples were also stored in -80 Celsius degrees for future analyses.

      Each participant received in each visit prepackaged the quantity of capsules until the next
      scheduled visit, and the used empty blisters were returned in the following visit in order to
      assess compliance in capsules consumption. 24-hour diet recalls were used to assess
      compliance to diet.

      In each visit an investigation concerning potential adverse events was made and data were
      recorded.

      A communication was obtained with each participant who discontinued the study before 24
      weeks, the reasons for discontinuation were recorded and data obtained until their last visit
      before study discontinuation were used in analyses.

      Paired analyses were made using the system Statistical Package for the Social Sciences
      comparing all study groups before and after the intervention.
    

Intervention name(s): Hydroxytyrosol; Diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months; Consultation by a dietitian was offered to all participants
Intervention MeSH terms: 3,4-dihydroxyphenylethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Administration of hydroxytyrosol (15mg versus 5 mg daily) versus placebo for 6 months in combination with diet in order to assess effects in body weight, body fat mass and visceral fat mass loss
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hydroxytyrosol; Body weight; Visceral fat