Impacts of Fermented Pea- and Legume-based Product High in Protein on Gut Microbiota and Health: a Randomized, Single-blinded, Controlled, Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- P-hs-CRP (mg/l)
研究概览
简要总结
This study aims to investigate the effects of consuming fermented pea- and legume-based product on gut and overall human health. It is a randomized, single-blinded, controlled, cross-over trial with a dietary intervention.
A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented pea- and legume-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out).
During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.
详细描述
Plant-based protein sources, such as those derived from peas and legumes, are experiencing high demand due to their role in reducing reliance on animal products and promoting a more sustainable food system. Despite this, there is limited information available regarding the impact of components like fibre in plant-based foods on protein and other nutrients' metabolism. In addition, the evidence of the health effects of meat alternatives is still scarce.
Food fermentation emerges as a potential solution to enhance the absorption of plant-based protein and various nutrients in the small intestine. This is achieved by reducing antinutrients and facilitating the absorption process. Additionally, food fermentation has implications for the composition and metabolic activity of the gut microbiota, influencing metabolism, immune responses, intestinal function, and overall health. The metabolism of tryptophan in the gut, modulated by the gut microbiota and the production of various metabolites, may serve as a key link in these observed health effects.
The fermentation of plant-based foods potentially enhances their beneficial health effects, and investigating this contributes to an increased understanding of the gut-mediated health effects of foods and the mechanisms behind them. This study is part of a European research project HealthFerm.
Detailed objectives are to:
- compare fermented and unfermented pea- and legume-based food products on blood lipid and glucose metabolism and gastrointestinal comfort as well as perceived and observed overall well-being.
- study the effects of fermented and unfermented pea- and legume-based food consumption on gut permeability and inflammation markers.
- study the difference in microbiota composition, diversity, and its contribution to cardiometabolic outcomes after consuming fermented and unfermented pea- and legume-based food products .
- study the difference in microbiota-related metabolites, especially tryptophan metabolites, between fermented and unfermented pea- and legume-based food products.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waist circumference >90 cm (women) or >100 cm (men) OR BMI 27-35 kg/m2
- •One of the following:
- •raised blood pressure (systolic ≥ 130 mmHg and/or diastolic 85 mmHg)
- •raised fasting plasma glucose (≥ 5.6 mmol/l)
- •raised triglycerides (≥ 1.7 mmol/l)
- •raised total cholesterol (≥ 5 mmol/l)
- •raised LDL (≥ 3 mmol/l)
- •reduced HDL (women < 1.3 mmol/l, men 1.0 mmol/l)
- •Consumption of at least one meal where the main protein source is meat, fish, or meat alternative on most days
- •Willingness to follow intervention diets for the whole study
排除标准
- •Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., type 1 or 2 diabetes, chronic liver, thyroid, kidney, or gastrointestinal diseases
- •Pregnancy and lactation
- •Gluten-free or vegan diet
- •Recent use of antibiotics (within 3 months)
- •Gastrointestinal surgery (within 6 months)
- •Alcohol abuse (AUDIT ≥ 15 p and measures of liver function)
- •regular smoking or use of snus or nicotine bags
研究组 & 干预措施
Unfermented product
Participants consume an unfermented pea- and legume-based product daily for three weeks within their diet.
干预措施: Unfermented meat alternative (Other)
Habitual diet
Participants consume their habitual diet without any intervention products.
Fermented product
Participants consume a fermented pea- and legume-based product daily for three weeks within their diet.
干预措施: Fermented meat alternative (Other)
结局指标
主要结局
P-hs-CRP (mg/l)
时间窗: Weeks 3, 6, 9, and 12
IL-22
时间窗: Weeks 3, 6, 9, and 12
LBP (μg/ml)
时间窗: Weeks 3, 6, 9, and 12
次要结局
- Changes in the composition gut microbiota(Weeks 3, 6, and 12)
- Short-chain fatty acids assessed from plasma samples(Weeks 3, 6, 9, and 12)
- Glucose metabolism(Weeks 3, 6, 9, and 12)
- fP-Insu (mU/l)(Weeks 3, 6, 9, and 12)
- Lipid metabolism(Weeks 3, 6, 9, and 12)
- Tryptophan metabolism(Weeks 3, 6, 9, and 12)
- Self-reported overall health (Short Form-36 Health Survey, SF-36)(Weeks 3, 6, 9, and 12)
- Self-reported mental health (General Health Questionnaire-12, GHQ-12)(Weeks 3, 6, 9, and 12)
- Self-reported gastrointestinal symptoms (Gastrointestinal Symptoms Rating Scale, GSRS)(Weeks 3, 6, 9, and 12)
研究者
Marjukka Kolehmainen
Professor
University of Eastern Finland