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临床试验/NCT04317079
NCT04317079已完成不适用

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

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年10月30日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandros Kokkinos

Associate Professor in Internal Medicine

National and Kapodistrian University of Athens

研究点 (2)

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