Exploratory Study of the Interindividual Variation in Response to Consumption of a Polyphenol-rich Green Coffee and Factor Influencing the Response
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The study is a multifaceted approach to investigate the effects of regular consumption of green coffee rich in polyphenols (hydroxycinnamic acids) on weight, body composition, cardiometabolic and inflammatory biomarkers in a sample population of overweight and obese people aimed at identifying a population of responders to green coffee experimenting the highest benefit from this product, and to contribute to the understanding of the influence of some of the main factors on the response to green coffee and their association with the differences between individuals (high-responders vs. low-responders).
详细描述
A randomized, cross-over, blind clinical trial will be carried out to evaluate the health effects of a polyphenol-rich green (slightly roasted) coffee in comparison with traditional roasted coffee to identify high- and low-responders.
Participants will consume the green and roasted coffee in a randomized order during 12 weeks, separated by a 4-week wash-out (and a previous 2-week run-in). Fasting blood samples will be collected in each of the 6 visits to the research centre. Blood pressure and body composition and anthropometric variables will be measured. In addition, urine and fecal samples will be obtained at the beginning and end of each intervention stage to analyze the bioavailability and metabolism of phenolic compounds, and the intestinal microbiota, respectively. Physical activity and energy expenditure will be measured in each of the interventions.
Besides a thorough cardiometabolic and inflammatory characterization of the volunteers, the frequency of specific genotypes (related with obesity, energy metabolism, inflammation and coffee intake) will be analyzed, as well as lifestyle and dietary habits of the participants, including aspects such as chrono-nutrition, sleep quality and wellbeing perception with the aim to contribute to clarify the determinants of inter-individual variability in the health effects of coffee bioactive phenolic compounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Coffee is provided as ground coffee in unmarked 1 kg packets labeled A or B for blinding, with instructions on how to prepare the coffee brew. The polyphenol-rich coffee is slightly roasted to emulate flavor, color and aroma for blinding.
Assessor will only be presented results marked as intervention A and B. Only the PIs will know the order in which both coffees were consumed by volunteers
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 25-35 kg/m2
排除标准
- •Vegetarian/Vegan
- •Pregnant/lactating women
- •On prescription drugs other than for thyroid/hypertension/dyslipemia, or changes in dosage in the last 3 months.
- •Consumption of vitamins or dietary supplements
- •On weight-reduction dietary regime or physical training to reduce body weight
- •Having taken antibiotics 3 months before starting the intervention
- •Intestinal, hepatic or renal diseases, coffee intolerance
结局指标
主要结局
Body weight
时间窗: 12-week
Change in body weight (estimated 2.5 kg) at the end of the intervention
Body fat percentage
时间窗: 12 weeks
Change in body fat percentage (total and visceral) at the end of the intervention
次要结局
- Insulin levels(12 weeks)
- Blood lipids(12 weeks)
- Blood glucose(12 weeks)
- Insulin sensitivity(12 weeks)
- Inflammatory cytokines(12 weeks)
- Insulin resistance(12 weeks)
- Glycated hemoglobin(12 weeks)