ISRCTN14236593进行中（未招募）Unknown
Effect of mandarin orange consumption on omics biomarkers and cardiometabolic phenotypes: A Randomized clinical trial in the general population (MANSomics)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 主要终点
- Changes in multi-omics biomarkers (gene-expression, DNA-methylation, and plasma metabolites) from baseline to 15 days following a daily intervention with 1 kg of mandarin oranges in comparison with the control group. Gene-expression will be measured with a whole transcriptomics human array at baseline and after 15 days. DNA-methyation will be measured by a genome-wide methylation human array at baseline and after 15 days. Metabolomics will be measured in plasma by Nuclear Magnetic Resonance at baseline and after 15 days.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Volunteers recruited from the general population
- •Aged 18 to 55 years old
- •Body mass index (BMI) between 23 and 32 kg/m²
排除标准
- •Do not meet the inclusion criteria.
- •People allergic or intolerant to the consumption of oranges.
- •Pregnant women or breastfeeding period
- •Alcoholism or drug addiction
- •Individuals presenting the following current situations: infectious diseases, renal diseases, liver diseases, cancer, obesity, type 2 diabetes, or other pathologies that may bias the study.
结局指标
主要结局
Changes in multi-omics biomarkers (gene-expression, DNA-methylation, and plasma metabolites) from baseline to 15 days following a daily intervention with 1 kg of mandarin oranges in comparison with the control group. Gene-expression will be measured with a whole transcriptomics human array at baseline and after 15 days. DNA-methyation will be measured by a genome-wide methylation human array at baseline and after 15 days. Metabolomics will be measured in plasma by Nuclear Magnetic Resonance at baseline and after 15 days.
次要结局
- 1. Biochemical analysis with hematocrit, lipid profile, blood glucose, renal and hepatic function at baseline and after 15 days.2. Analysis of parameters related to oxidative stress at baseline and after 15 days.3. Measurement of blood pressure at the baseline visit and after the intervention at baseline and after 15 days.4. Weight, height, waist circumference, and body composition through baseline bioimpedance at baseline and after 15 days.5. Food intake and adherence to the Mediterranean Diet using the food consumption frequency questionnaire and the 14-point adherence questionnaire at baseline and after 15 days.6. Physical activity measured through the use of accelerometers at baseline and after 15 days.7. Characteristics of sleep measured using the Epworth Sleepiness Scale and chronotype assessed with the Morningness-Eveningness Questionnaire by Horne and Östberg at baseline and after 15 days.
研究者
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