Alternative Protein Short Chronic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day
研究概览
简要总结
The world's population needs adequate food supply to sustain food security. The availability of sufficient dietary protein is undeniably a source of concern for human health. This study aimed to assess the satiety and potential health benefits of two types of vegetarian diets when the meat was replaced with buckwheat and respectively fava bean for one-week in the diet of healthy volunteers.
详细描述
The World Health Organisation (WHO) recommends increasing the intake of fruits and vegetables, legumes, whole grains and nuts to prevent obesity. In Western countries, there is a greater understanding of the health benefits of pulse grains. Consumption of whole grain cereals and grain pulses has been shown to protect against a variety of inflammation-related chronic diseases. Grain cereals, pulses and pseudo cereals are also good dietary protein sources. This study aimed to assess the suitability of buckwheat and fava bean to replace meat for one week in terms of delivering adequate nutrient intake, satisfying hunger and delivering potential health benefits. The composition of human microbial metabolites and the bacterial composition after consumption of the intervention diets by healthy volunteers for one week were also assessed. This study offers data to support the potential of plants as alternative sources of dietary nutrients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females,
- •Non-vegetarian,
- •non-smokers,
- •age 18-65
- •with BMI 18-35 kg/m.
- •Exclusion criteria:
- •vegetarian,
- •having known allergies,
- •using prescription drugs.
- •diabetes,
- •gastrointestinal disorders,
- •kidney disease,
- •hepatic disease,
- •alcohol or
- •substance abuse
排除标准
- 未提供
结局指标
主要结局
The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day
时间窗: 7-days
The suitability of a vegetarian diet (buckwheat and fava bean based) to deliver sufficient nutrients per day such as protein composition, amino acids composition, fibre composition, types of NSP, and daily requirements minerals, microelements, and other bioactive such as polyphenolic phytochemicals. The macronutrient composition, including the dry matter, ash, fat, total carbohydrate, resistant starch, crude protein, and total non-starch polysaccharides of the buckwheat and fava-bean diets are measured in grams per day. The amino acid composition was measured in grams per day and the main micronutrients expressed in mg ± SD per day are measured in fava bean and buckwheat diets using quantitative ICP-MS analysis.
Satiety levels following the consumption of buckwheat and fava bean-based diets.
时间窗: every hour for 16 hours during the day for 7 days
Appetite scores were measured hourly during the waking hours (0700-2300) with the use of visual analogue scales (VASs) during both the habitual diet week and the intervention weeks (fava bean-based and buckwheat-based diets). Six questions were asked on motivation to eat, all in the line scale format related to hunger, thirst, preoccupation with thoughts of food, fullness, desire to eat, and prospective consumption. The scales ranged from "not at all hungry" to "extremely hungry," so higher scores indicated more intense subjective sensations. These questionnaires were completed by the subjects each day of the study.
Concentrations of plasma, urine, and faecal samples of microbial metabolites of carbohydrates, protein, and bioactive phytochemicals.
时间窗: Baseline and day 7
Concentrations of plasma, urine, and faecal samples of microbial metabolites of carbohydrates, protein and bioactive phytochemicals from the diets at day 0 and day 7 in fasted plasma, urine and faecal samples. Furthermore looked at fermentation products of carbohydrates in faecal samples. Average concentration was measured by targeted LC-MS/MS and expressed as pg/μl.
Hourly hunger scores analysed using VAS
时间窗: every hour for 16 hours during the day for 7 days
Hunger scores were measured hourly during the waking hours (0700-2300) with the use of visual analogue scales (VASs) during both the habitual diet week and the intervention weeks (fava bean-based and buckwheat-based diets). Six questions were asked on motivation to eat, all in the line scale format related to hunger, thirst, preoccupation with thoughts of food, fullness, desire to eat, and prospective consumption. The scales ranged from "not at all hungry" to "extremely hungry," so higher scores indicated more intense subjective sensations. These questionnaires were completed by the subjects each day of the study.
Gut microbiota composition: Bacterial DNA extraction and sequencing using 16sRNA to determine the bacterial composition following the two different vegetarian-based diets.
时间窗: 7-days
The total number of 16S rRNA gene copies per ml and abundance of several bacterial genera or species of the communities in the anaerobic faecal incubation experiments was determined by quantitative PCR with 2 ng DNA in a total volume of 10 μl and expressed as 16S rRNA gene copies per ml of culture. The abundance of total faecal microbiota and specific genera were reported during habitual (baseline) diet and intervention diets consumption.
次要结局
- Values concentration (μM) of fasted homocysteine(7-days)
- Values concentration (mmol/l) of fasted lipids, urea, and glucose(7-days)
- Values concentration (pmol/l) of fasted insulin(7-days)