NCT04317079

Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women

Evaluation of the Effects of the Administration of 5 Milligrams and 15 Milligrams of Hydroxytyrosol, an Extra Virgin Olive Oil Phenolic Compound, Versus Placebo, Combined With Diet, in Anthropometric Parameters in Overweight and Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Weight
• Visceral Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydroxytyrosol	Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months
OTHER	Diet	Consultation by a dietitian was offered to all participants

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2020-03-20
• Last updated: 2020-03-20

Locations

1 site across 1 country: Greece