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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overweight and obese women. Stable body weight (<5% variation) during the past 3 months before enrollment. Stable hypolipidemic treatment for at least 3 months before enrollment.
排除标准
- •Diabetes mellitus
- •Neoplasms
- •Autoimmune conditions
- •Psychiatric disorders (excluding stable depressive disorder)
- •Hyper/hypo-thyroidism with recent changes in medical treatment during the past 6 months before enrollment
- •Renal impairment, defined as estimated Glomerular Filtration Rate (MDRD) <60millilitres/min
- •Heart failure, defined as left ventricle Ejection Fraction <40%, use of diuretics or other treatment due to heart failure (antihypertensive medications allowed)
- •Impaired liver function, defined as liver transaminases values twice above the upper normal range
- •Malabsorption status (inflammatory bowel disease, previous bariatric surgery, chronic pancreatitis)
- •Medical treatment known to influence body weight (steroids, oestrogens/ progesterone, topiramate, mirtazapine or anti-obesity treatment)
- •Unwillingness to participate to the study
- •Baseline waist circumference >130cm due to technical difficulties in visceral fat measurement
- •Pregnancy, lactation
结局指标
主要结局
Change in body weight
时间窗: Baseline, 4,12 and 24 weeks
Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Change in body fat mass
时间窗: Baseline, 4,12 and 24 weeks
Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Change in visceral fat
时间窗: Baseline, 4, 12 and 24 weeks
Measurement via TANITA technology
次要结局
- Changes in blood insulin(Baseline, 12 and 24 weeks)
- Changes in blood lipids(Baseline, 12 and 24 weeks)
- Changes in blood glucose(Baseline, 12 and 24 weeks)
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens
