ISRCTN03372660已完成2 期
Effect of olive oil enriched in oleanolic acid on the incidence of type 2 diabetes mellitus in patients with pre-diabetes: a multicentre randomised double-blind controlled trial
Andalusian Regional Ministry of Health (Consejería de Salud de la Junta de Andalucía) (Spain)0 个研究点目标入组 176 人开始时间: 2009年11月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31364228 (added 01/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current information as of 09/11/09:
- •1. Men or women with an age range between 30 and 80 years
- •2. Body mass index = 25 kg/m^2 and < 40 kg/m^2
- •3. Acceptance to participate in the study and signed the corresponding informed consent
- •Initial information at time of registration:
- •1. Men or women with an age range between 30 and 80 years
- •2. Body mass index = 25 kg/m^2
- •3. Acceptance to participate in the study and signed the corresponding informed consent
排除标准
- •Current information as of 09/11/09:
- •1. Diabetes at the time of admission to the study:
- •1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload
- •1.2. 75 g of glucose = 200 mg/dl
- •1.3. Diabetes confirmed by a physician and confirmed by other clinical data
- •1.4. In antidiabetic treatment (oral and/or insulin)
- •2. Alcohol dependence syndrome or any other addiction
- •3. Physical, mental or intellectual limitation to take part in a study of dietary intervention
- •4. Difficulty or lack of predisposition to change food habits
- •5. Drugs or medical conditions that interfere with the diagnosis of diabetes:
- •5.1. Beta-blockers
- •5.2. Systemic glucocorticoids
- •5.3. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction
- •5.4. Other drugs for weight reduction (orlistat and sibutramine)
- •5.5. Thyroid Disease suboptimal treatment
- •5.6. Other endocrine diseases (such as Cushing's disease, acromegaly)
- •5.7. Fasting triglycerides > 600 mg/dl despite treatment
- •6. Conditions or circumstances which may affect the conduct of the trial:
- •6.1. Inability to communicate with the researchers conducting the intervention
- •6.2. Not willing to accept the treatment assigned by randomisation
- •6.3. Participation in another project that could interfere with this project
- •6.4. Loss of weight for any reason superior to 10 % in the last three months, except postpartum
- •6.5. Inability to walk 400 meters in 10 minutes without stopping
- •7. Cancer in the last 5 years that needed treatment, unless the prognosis is good
- •8. Systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg
- •9. Pregnant women of childbearing age, if:
- •9.1. Currently pregnant or within 3 months postpartum
- •9.2. Lactating
- •9.3. Pregnancy planned during the study period
- •Initial information at time of registration
- •1. Diabetes at the time of admission to the study:
- •1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload
- •1.2. 75 g of glucose = 200 mg/dl
- •1.3. Diabetes confirmed by a physician and confirmed by other clinical data
- •1.4. In antidiabetic treatment (oral and/or insulin)
- •2. Alcohol dependence syndrome or any other addiction
- •3. Physical, mental or intellectual limitation to take part in a study of dietary intervention
- •4. Difficulty or lack of predisposition to change food habits
- •5. Drugs or medical conditions that interfere with the diagnosis of diabetes:
- •5.1. Thiazide diuretics
- •5.2. Beta-blockers
- •5.3. Systemic glucocorticoids
- •5.4. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction
- •5.5. Other drugs for weight reduction (orlistat and sibutramine)
- •5.6. Thyroid Disease suboptimal treatment
- •5.7. Other endocrine diseases (such as Cushing's disease, acromegaly)
研究者
相似试验
已完成
不适用
Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)Cardiometabolic RiskNCT05771571University of the Aegean21
已完成
2 期
The effect of olive oil rich diet consumption on serum omentin concentratioCondition 1: Serum omentin concentration in owerweight women. Condition 2: Overweight.-Obesity due to excess caloriesIRCT138812223550N1Tehran University of Medical Sciences16
已完成
不适用
Crossover study of diets enriched with virgin olive oil, walnuts or almonds. Effects on lipids and other cardiovascular risk markersISRCTN68210440International Nut and Dried Fruit Foundation (Spain)20
已完成
不适用
The Effect of Olive Leaf Extract Administration on Cardiovascular HealthOverweight and ObesityElevated CholesterolNCT02990637Maastricht University Medical Center80
已完成
2 期
The effect of consuming olive oil in patients with depressioDepression.Depressive episodeIRCT2016041820140N3Vice Chancellor for Research of Shiraz University of Medical Sciences73