Influence of Proteins on the Bioavailability of Carotenoids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Concentration of carotenoids in plasma triacyl-rich-lipoprotein (TRL) fraction
研究概览
简要总结
A postprandial intervention study is conducted on healthy male subjects to evaluate whether the addition of proteins (why protein isolate, soy protein) can help to increase the bioavailability of carotenoids from a tomato/carrot beverage.
详细描述
Participants who agree to sign the Informed Consent Form and are considered eligible for participation will be scheduled for a first and brief screening visit enrolment visit) to collect a spot urine and blood sample (20 ml) that are meant to check the subjects anemic status and analyze the sugar levels as well as plasma lipids such as triglycerides, in order to screen for any abnormal health condition (e.g. onset of diabetes) that they might not be aware of at the date of the information session and that might not make them eligible for this study.
If at this stage they are still considered eligible for the study, participants will commence the 4 week trial phase which includes 3 washout periods, 1 short screening visit and 3 full day (i.e. 10.5 hours) clinical visits. The screening visit, called preliminary visit, will take place at the beginning of the trial phase. A blood sample will be collected to determine the baseline levels of triglycerides and plasma carotenoids at the beginning of the trial, prior to the first washout phase.
The first washout week starts on day 1 after the preliminary visit and will have a duration of 14 days during which the participants will be asked to stay on a low carotenoid diet (i.e. to avoid the intake of colored fruits and vegetables), to reduce the basal levels of blood circulating carotenoids.
During the 1-day appointments at the Clinical and Epidemiological Investigation Centre (CIEC), one of the three test meals will be given to the participants in 6 different orders, making 6 treatment patterns. Assuming that all 24 participants are successfully recruited, we will have 4 randomly allocated participants per pattern.
On clinical visit days, participants will be asked to report at the CIEC's facilities, starting from 7:30 am, and a baseline blood sample (20 ml) will be drawn at 0h time point. A trained nurse will insert a cannula in the forearm of the participant that will be left in place during the whole staying for the commodity of the participant.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy and free living;
- •age between 20 and 50 years old;
- •Body-Mass-Index (BMI) <30 kg/m2
- •non-smokers (abstinent for more than 2 years);
排除标准
- •suffering from any metabolic disease that may cause digestive disturbances (such as Crohn's disease or colitis);
- •malabsorption disorders;
- •BMI over 30 kg/m2;
- •hyperlipidaemia (triglycerides and total cholesterol over 200 mg/dl)
- •any individuals following a special diet that is not compatible with wash-out periods or test meals (vegetarian, gluten-free or diabetic);
- •regular consumption of more than 5 portions (80-100 g) of fruits and vegetables per day;
- •being on medical treatment or consuming any medication for chronic conditions or recent illness (e.g. antibiotics);
- •consuming regularly dietary supplements;
- •abnormally high or low values of plasma circulating carotenoids;
- •tobacco smoking;
- •frequent alcohol consumption (over 2 glasses per day);
- •food allergies or intolerances that are not compatible with test meals (e.g. gluten or milk intolerance);
- •daily practice of intense physical activity of 120 min or more.
- •No special population group such as prisoners, children, the mentally disabled or groups whose ability to give voluntary informed consent may be in question, will be recruited for this study.
结局指标
主要结局
Concentration of carotenoids in plasma triacyl-rich-lipoprotein (TRL) fraction
时间窗: 10 hours postprandial, measured on 3 test clinical test days after test meal intake, interspersed by 1 week each
Carotenoid concentration (lycopene, beta-carotene) studied over 10 hours postprandial (area-under curve of concentration vs. time)
次要结局
- Time of maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction(10 hours postprandial, measured on 3 clinical test days after test meal intake, interspersed by 1 week)
- Maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction(10 hours postprandial, measured on 3 test clinical days after test meal intake, interspersed by 1 week)
- Fecal degradation products of carotenoids(Collection covering the test meal intake period, starting from the excretion of a brilliant blue capsule taken the 12 hours before test meal intake, until complete excretion of a second brilliant blue capsule taken 24 hours after test meal intake)