OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Changes in inflammation markers
研究概览
简要总结
The overall objective of this research entity is to reveal the comprehensive health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the lipids, short-chain fatty acids, inflammation markers and antioxidant status from plasma, fecal microbiome, and plasma metabolome. Additionally the effect of the 6-week diet on postprandial glycemia and postprandial satiety and vitality are investigated.
详细描述
Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study, with metabolically challenged volunteers on oat-rich low-gluten diet, are to:
- Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut and general well-being and dietary intake.
- Investigate changes in fecal microbiome, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low-gluten diets.
- Examine the impact of the oat or rice-rich low-gluten diet on the change in metabolite profiles in blood by non-targeted metabolomics approach.
- Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as biomarkers.
- Discover how the long-term consumption of oats and rice and their possible alterations in fecal microbiome affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma SCFAs).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Commits to follow the instructed low-gluten diet for 6 weeks
- •30 - 68 years of age
- •BMI > 25 kg/m^2
- •High cholesterol (without medication) characterized as total cholesterol > 5 mmol/l, AND either LDL > 3 mmol/l OR HDL (men/women) < 1.0/1.2 mmol/l AND/OR Hypertension (systolic > 140 mmHg or diastolic > 90 mmHg).
排除标准
- •Regular medication that can affect the research outcomes (balanced medication for hypertension, hypo-/hyperthyroidism, hormone replacement therapy, and inhaled medicines allowed)
- •Pregnancy or lactation
- •Heavy smoking
- •Recent course of antibiotics (less than 3 months prior to the study)
研究组 & 干预措施
Oat-rich and low-gluten diet with oat-rich meal test
Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast.
干预措施: Dietary intervention (Other)
Oat-rich and low-gluten diet with oat-rich meal test
Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast.
干预措施: Postprandial meal test (Other)
Rice-rich low-gluten diet with oat-rich meal test
Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast.
干预措施: Dietary intervention (Other)
Rice-rich low-gluten diet with oat-rich meal test
Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast.
干预措施: Postprandial meal test (Other)
Oat-rich low-gluten diet with rice-rich meal test
Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast.
干预措施: Dietary intervention (Other)
Oat-rich low-gluten diet with rice-rich meal test
Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast.
干预措施: Postprandial meal test (Other)
Rice-rich low-gluten diet with rice-rich meal test
Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast.
干预措施: Dietary intervention (Other)
Rice-rich low-gluten diet with rice-rich meal test
Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast.
干预措施: Postprandial meal test (Other)
结局指标
主要结局
Changes in inflammation markers
时间窗: Week 0 and 6
The inflammation markers in plasma are measured as a baseline before the study and after 6 week diet intervention. The markers will be analysed with cDNA multiplex immunoassay and qPCR giving semi-quantitative results on a log2 scale (Olink inflammation panel, Olink Proteomics, Uppsala, Sweden). The panel contains at least 92 different proteins that are related to inflammation.
Changes in neuropsychological performance: cognitive load
时间窗: Week 0 and 6
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the cognitive load (Serial Sevens Task) test.
Changes in neuropsychological performance: reaction time and attention
时间窗: Week 0 and 6
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the reaction time and attention (Color Word Stroop test) test.
Changes in neuropsychological performance: response control
时间窗: Week 0 and 6
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the response control (Cued Go/No-Go Task) test.
Changes from baseline in plasma short-chain fatty acids
时间窗: Week 0 and 6
Samples are taken 90 and 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states.
Changes from baseline in plasma antioxidant capasity
时间窗: Week 0 and 6
Plasma samples are taken 180 min after consuming the study meal, and at the fasting state, before and after the 6-week diet intervention to see the change between fasting state and postprandial states. The antioxidant status of plasma will be analysed with commercial kits for 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulfonic acid (ABTS) and Oxygen Radical Absorbance Capacity (ORAC) (Merck KGaA, Darmstadt, Germany) to measure antioxidant capacity of plasma.
Changes in blood lipid
时间窗: Week 0 and 6
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood lipid development curve in postprandial state.
Changes in glucose status
时间窗: Week 0 and 6
Postprandial plasma samples are taken at the fasting state and 15, 30, 45, 60, 90, 120 and 180 min after consuming the study meal before, and after the 6-week diet intervention to see blood glucose development curve in postprandial state.
Changes from Baseline in Serum Total Cholesterol
时间窗: Week 0 and Week 6
Serum total cholesterol will be measured from fasting blood samples at the baseline (week 0) and after 6 week of the dietary intervention (week 6).
Changes from Baseline in Interleukin-10
时间窗: Week 0 and Week 6
Interleukin-10 is measured from fasting plasma samples at the baseline (week 0) and after the 6-week diet intervention (week 6). It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation.
次要结局
- Changes in gut microbiota(Week 0 and 6)
- Changes in gastrointestinal symptoms(Weeks 0 and 6)
- Changes in excreted bile acids(Week 0 and 6)
- Changes from Baseline in Blood Lipids(Week 0 and Week 6)
- Changes from Baseline in Glucose Metabolism(Week 0 and Week 6)
- Changes in Postprandial Glucose metabolism(0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6)
- Changes from Baseline in Inflammation markers(Week 0 and Week 6)
- Changes from Baseline in Plasma metabolome(Week 0 and Week 6)
- Changes from Baseline in Plasma Tryptophan Metabolites(Week 0 and Week 6)
- Changes from Baseline in plasma Short-Chain Fatty Acids(Week 0 and Week 6)
- Changes in Postprandial status of Peptide-YY (PYY) concentrations(0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6)
- Changes from Baseline in Plasma Antioxidant Capacity(Week 0 and Week 6)
- Changes from Baseline in Fecal Microbiome(Week 0 and Week 6)
- Changes from Baseline in Blood Pressure(Week 0 and Week 6)
- Changes from baseline in Anthropometric measurements(Weeks 0 and 6)
- Changes from baseline in Dietary intake and Diet quality(Week 0 and Week 6; FFQ on Week 0, 3 and 6)
- Changes from Baseline in Bowel movement frequency and Stool types(Week 0 and Week 6)
- Changes from baseline in Gastrointestinal symptoms by GSRS(Weeks 0 and Week 6)
- Changes from baseline in Perceived well-being by RAND-36(Weeks 0 and Week 6)
- Changes in Neuropsychological Performance: Cognitive Load(0 and 60 minutes after the study meal at week 0 and week 6)
- Changes in Neuropsychological Performance: Reaction Time and Attention(0 and 60 minutes after the study meal at week 0 and week 6)
- Changes in Neuropsychological Performance: Response Control(0 and 60 minutes after the study meal at week 0 and week 6)
研究者
Kaisa Linderborg
Professor
University of Turku