Promephy - Metabolic Fate of Plant-based Proteins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Amino acid Profile
研究概览
简要总结
The PROMEPHY study aims to assess differences between animal versus plant-based proteins on metabolic and physiological parameters in healthy adults. It is envisaged that the results from this study will provide important and novel insights into the potential health-benefits of regular consumption of plant-based proteins. This may enable future application in products available to the consumer.
The main objective of this study is to compare the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a plant-based protein mix with the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a milk protein isolate. In addition this study will aim to assess the impact of different protein sources on gut microbiota and proteome composition to determine the potential health impact of consumption of plant-based proteins.
详细描述
Few human intervention studies have examined the short term (<4 weeks) effects of high (plant and animal) protein diets (25-30 percent of total energy intake) on intestinal microbiota composition [Beaumont et al., 2017; David et al., 2014]. One study suggests that long-term dietary patterns which involve increased consumption of protein (meat and dairy) can shift the composition of the gut microbiota towards an ecosystem in which taxa possessing proteolytic fermentation pathways are most abundant [Blachier et al., 2019]. Increased proteolytic activity is associated with increased gene expression of negative bacteria and increased uremic toxins and microbial metabolites which can potentially result in damage to the gut microstructure, activation of immune/ inflammatory responses which over a prolonged period of time may have negative health outcomes [Windey et al, 2012]. These system-level shifts in composition and metabolism hint at the complexity of metabolic interactions occurring in the host-microbiome symbiosis, but more information is needed on the processes underlying these changes.
There is current interest in the functional benefits of plant-based proteins, but with a lower bioavailability it is unclear as yet what the metabolic fate of these proteins is. Furthermore, relative to dairy proteins, plant-based sources of protein have different compounds within the structure, such as micronutrients and fibre and it is unclear if these compounds can modulate the potential negative impact of high diary protein diets on the microbiome.
The PROMEPHY study will focus on better understanding the metabolic and physiological impact of high protein diets from different (alternative) protein sources in humans. The results will provide novel insights into plant-based protein sources and may enable future application in products available to the consumer.
The primary objective of this study is to compare the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a plant based protein mix with the changes in serum essential amino acid bioavailability after two weeks of daily consumption of a milk protein isolate.
Secondary objectives of this study are:
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, Investigator)
盲法说明
Protein supplements will be provided in a randomized, double-blinded manner. Both the participants and research testers will be masked from knowing the specifics of the supplement intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 50 years
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
- •Written informed consent
- •Willingness and ability to comply with the protocol
- •Willingness to use a method of birth control during participation in the study (women only)
- •Judged by the investigator to be in good health
排除标准
- •Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.
- •Known cardiovascular disease, disease related to the immune system and/or the respiratory system
- •Known renal or hepatic failure or known thyroid dysfunction
- •Known Diabetes Mellitus type I or type II
- •Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment
- •Haemoglobin (Hb) in men <7.5 mmol/l and in women <7.0 mmol/l at screening
- •Any known bleeding disorder
- •Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, anticoagulants within 3 weeks of Visit 1
- •Use of antibiotics within 3 months prior to Visit 1
- •Known lactose intolerance or known plant-based protein allergy
- •Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/high protein diet or a weight loss program)
- •Use of any nutritional supplements or additional protein supplements or nutritional support within 6 weeks prior to visit 1
- •Regular heavy and/or extreme exercise (e.g. trained elite athletes) in opinion of the investigator
- •Known pregnancy and/or lactation (women only)
- •Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month) and willingness to stop entirely during study participation (after enrolment).
- •Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months) or drug/ medicine abuse in opinion of the investigator
- •Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1
- •Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
结局指标
主要结局
Amino acid Profile
时间窗: Change from beginning (day 1) to end of each trial (day 14)
Measurement of essential amino acids (EAA; umol/L) area under the curve (iAUC) after two weeks of study product intake of plant based protein mix vs dairy protein mix
次要结局
- Microbiota profile(Change from beginning (day 1) to end of each trial (day 14))
- Proteome data(Change from beginning (day 1) to end of each trial (day 14))
- Uremic blood markers(Change from beginning (day 1) to end of each trial (day 14))
研究者
Justin Roberts
Professor
Anglia Ruskin University