Development of Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis: From Farm to Fork to Health (MITOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Changes in brain-derived neurotrophic factor (BDNF) after each intervention with tomato paste and the control intervention.
研究概览
简要总结
Tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (MGBA) interactions due to their high content of fiber and phytochemicals. Phytochemical metabolites derived from the consumption of tomato-based products can act directly as neurotransmitters in the central nervous system, crossing the blood-brain barrier, or indirectly by modulating the MGBA. These metabolites can thus alter gut bacterial composition and brain biochemistry. Therefore, researchers propose a new interventional study to assess the impact of daily tomato consumption in the organism, and to evaluate the effect on the MGBA. The final aim of this study is to spread a message of the health benefits of tomato consumption for the general population.
详细描述
To evaluate the possible changes in microbiota and cognitive skills after consumption of tomato paste in a crossover randomized controlled study. Fifty healthy adults subjects (aged 40-55 years and consisting of 50% males and 50% females to assess possible sex-based responses) will be included. Participants will sign the informed consent and carry out a washout period without consuming any tomatoes or tomato-based products during 1 week. Participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (experimental intervention), and the normal diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (control intervention) during 3 months. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hours urine, feces, and saliva) will be obtained at baseline and the end of each arm of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult subjects with BMI < 30 kg/m2
- •Signed informed consent
排除标准
- •Participants with tomato allergy or intolerance
- •Cardiovascular disease (cancer or diabetes)
- •Mental disorders (e.g. depression, dementia, autism, etc.)
- •Cardiovascular alterations in triglycerides or glucose
- •Participants with body mass index (BMI) > 30 kg/m2
- •Current smokers
- •Frequent use of corticoids, nonsteroidal anti-inflammatory drugs
- •Volunteers with extreme eating habits (i.e. Atkins diet, very high protein diets, etc.)
- •Excessive alcohol consumption (>30 g/d for males and >20 g/d for females),
- •Pregnant or lactating women
结局指标
主要结局
Changes in brain-derived neurotrophic factor (BDNF) after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
Serum samples will be analysed for mature BDNF using a Mature BDNF Rapid ELISA kit.
Changes in cognitive function (executive) after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
The Wisconsin Sorting Cards Test (WSCT) will assess strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behaviour towards achieving a goal and modulating impulsive responding.
Changes in cognitive function (memory) after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
The face-name associative memory exam (FNAME) will assess associative memory function.Participants will be asked to remember a set of faces and the names they are paired with. After a 5-25 minute delay, participants will recall which of the faces and names they saw earlier.
Changes in the polyphenols and carotenoids and their metabolites after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
Carotenoids and polyphenols, and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using High Performance Liquid Chromatography HPLC-LTQ-Orbitrap-MS/MS and HPLC-MS/MS techniques.
Changes in the short-chain fatty acids in plasma and feces samples after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
After acidifying the fecal samples with formic acid, a quantification of short-chain fatty acids will be performed using gas chromatography by direct injection according to previously described methodology (Zhao et al., 2006).
Changes in bile acids in plasma and feces samples after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
Bile acids will be assayed using a validated liquid chromatography-mass spectrometry (LC-MS) method
Changes in cognitive function (attention) after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
The d2 Test will meausure selective and sustained attention and visual scanning speed. Processing speed, rule compliance, and quality of performance will be assess in participants.
Changes in cerebrovascular function after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
Cerebrovascular function will be measured using functional magnetic resonance imaging (FMRI), a non-invasive method for assessing brain activity. FMRI maps blood oxygenation levels in the brain and estimates changes in the blood flow that depends on metabolic function and is correlated with specific brain region activities
Changes in the gut microbiota after each intervention with tomato paste and the control intervention.
时间窗: Baseline and after completed each intervention (3 months)
Fecal samples will be collected by the volunteers using a system for easy self-collection and stabilization of microbial DNA for gut microbiome profiling (OMNIgene - GUT). The genomic DNA will be extracted from fecal samples using the DNeasy PowerSoil Kit. Then, microbial profiling using 16S ribosomal RNA (rRNA) sequencing will be used to study microbial communities, specially bacterial phylogeny and taxonomy.
次要结局
- Changes in body composition after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in heart rate after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in Body mass index after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in waist-to-hip ratio with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in anthropometric measurements after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in blood pressure after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in pro- and anti-inflammatory biomarkers after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in lipidic profile after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in liver function after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in glucose after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in nutrients and energy intake after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in quality of the diet after each intervention with tomato paste and the control intervention.(Baseline)
- Changes in physical activity after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in sleep quality after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Changes in quality of life after each intervention with tomato paste and the control intervention.(Baseline and after completed each intervention (3 months))
- Sensory threshold and organoleptic analysis(Baseline)
研究者
Rosa M Lamuela-Raventós
Professor
University of Barcelona