Health Effects of Chronic Supplementation with a Natural Extract High in Hydroxytyrosol in Individuals At High Risk of Developing Age-related Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- LDL-ox as marker of oxidative status
研究概览
简要总结
The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.
详细描述
Fifty subjects 40-75 years old overweight (BMI between 24-29,9 kg/m2) and prediabetes (fasting blood sugar between 100-126 mg/dl and/or glycated hemoglobin between 5,7-6,4%) will be recruited. Detailed inclusion and exclusion criteria are provided below.
Participants will be randomly divided into two groups, one to consume the Hytolive® capsule and the other a placebo. The intervention study has been designed for daily consumption before breakfast of one capsule for 16 weeks. The study includes a two-week washout period during which subjects will not be allowed to consume olives or virgin olive oil.
At the beginning and end of the study, upon arrival at the ICTAN-CSIC Human Nutrition Unit, volunteers will provide a urine sample corresponding to the first morning void, and a nurse will draw a fasting blood sample (20 mL distributed in tubes with various anticoagulants for measurements). Additionally, their blood pressure will be measured, and a complete anthropometric and body composition study will be conducted. Furthermore, volunteers will provide a stool sample from the preceding days (these samples will not be used in this study but will be stored at -80°C for potential future determination of the intestinal microbiota metagenomic profile). Subsequently, dietary controls will be conducted, physical activity and emotional well-being tests will be administered, and fatigue will be evaluated. Additionally, there will be an interim visit aimed at verifying adherence to supplementation. For this purpose, volunteers will provide a urine sample corresponding to the first morning void on an empty stomach, in which levels of hydroxytyrosol and its derivatives will be determined. Likewise, dietary and physical activity controls will be conducted to confirm that volunteers are not altering their habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prediabetes (defined as fasting glucose levels according to the American Diabetes Association guideline, with fasting blood glucose ≥100 and <126 mg/dL, or hemoglobin A1c levels ranging from 5.7% to 6.4%)
- •Overweight (body mass index BMI 24-29.9 kg/m2)
排除标准
- •Any prior diagnosis of diabetes, hypertension, hyperlipidemia, other cardiovascular diseases, thyroid gland disorders, asthma, arthritis, or inflammatory conditions, cirrhosis, or other liver diseases
- •Weight loss > 2.5 kg in the last 6 months
- •Being on pharmacological treatment of any kind
- •Taking dietary supplements containing antioxidants other than vitamins
- •Being a smoker or habitual alcohol consumer; being HIV positive
- •Being pregnant or breastfeeding
- •Blood pressure ≥ 140 mmHg (systolic) and ≥ 90 mmHg (diastolic)
- •Total cholesterol ≥ 240 mg/dL, LDL cholesterol ≥ 160 mg/dL, or TG ≥ 200 mg/dl
研究组 & 干预措施
Capsule of an olive extract with a high content of hydroxytytorosol. Group 1
Intake of one capsule/day containing 15 mg of hydroxytyrosol before breakfast for 16 weeks.
干预措施: Group 1, hydroxytyrosol-rich extract capsule (Dietary Supplement)
Capsule of placebo. Group 2
Intake of one capsule placebo/day without hydroxytyrosol before breakfast for 16 weeks.
干预措施: Group 2, capsule of placebo (Dietary Supplement)
结局指标
主要结局
LDL-ox as marker of oxidative status
时间窗: Up to six months
Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects
次要结局
- Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale(Up to two months)
- Glucagon-like peptide-1 (GLP-1)(Up to six months)
- Total cholesterol(Up to six months)
- Sleep quality determined by Pittsburgh Sleep Quality Index(Up to two months)
- Fatigue test determined by Borg Rating Of Perceived Exertion(Up to two months)
- Fasting glucose(Up to six months)
- Fasting insulin(Up to six months)
- Glycated hemoglobin (HbA1c)(Up to six months)
- Low density lipoproteins (LDL)(Up to six months)
- High density lipoproteins (HDL)(Up to six months)
- Triglycerides(Up to six months)
- Apoliporpotein A1(Up to six months)
- Apoliporpotein B(Up to six months)
- Total antioxidant status (TAS)(Up to six months)
- Total oxidative status (TOS)(Up to six months)
- Interleukine 6 (IL-6)(Up to six months)
- Aspartate aminotransferase (transaminase AST)(Up to six months)
- Oxides of nitrogen (NOx)(Up to six months)
- Thiobarbituric acid reactive substances (TBARS)(Up to six months)
- C reactive protein(Up to six months)
- Tumor necrosis factor alpha (TNF-α)(Up to six months)
- Alanine aminotransfesare (transaminases ALT)(Up to six months)
研究者
María Raquel Mateos Briz
Investigator
National Research Council, Spain