Tolerance of Regular Meal Intake With Mycoprotein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in gastro intestinal (GI) complaints
研究概览
简要总结
This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
详细描述
Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.
The primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.
The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and women (based on questionnaire)
- •Age between 18 and 70 years
- •Body mass index (BMI) between 18.5 and 29.9 kg/m2
排除标准
- •Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease), judged by the medical doctor
- •History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- •History of liver dysfunction (cirrhosis, hepatitis)
- •Kidney dysfunction (self reported)
- •Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
- •Reported slimming or medically prescribed diet
- •Current smokers
- •Alcohol intake over 4 glasses of alcoholic beverages per day
- •Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
- •Abuse of illicit drugs
- •Having food allergies
- •Participation in another clinical trial at the same time
- •Being an employee of the department Consumer Science and Health group of Wageningen Food and Biobased Research
研究组 & 干预措施
Fermotein™
daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger
干预措施: Fermotein based meals (Other)
Matched control products
daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket.
干预措施: Matching control meals with whey protein and wheat bran (Other)
结局指标
主要结局
Change in gastro intestinal (GI) complaints
时间窗: Daily, during 18 days of Fermotein™ intake and up to three days after intake.
Determined by combining multiple outcome measures ( bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation) measured via questionnaires with Visual Analogue Scale (VAS) scores; from no complaints (minimal) to serious complaints (maximum). Higher values represent a worse outcome.
次要结局
- change in blood hemoglobin(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood ferritin(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood cholesterol (total)(before and after 18 days consumption of Fermotein™ or control product)
- change in blood glucose(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood ASAT(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood leukocyte cell counts(at baseline, and after 18 days of fermotein or control product consumption)
- change in blood insulin(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood pressure(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood Fe (iron)(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood ALAT(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood GGT(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood creatinine(at baseline, and after 18 days of Fermotein™ or control product consumption)
- change in blood zonulin(at baseline, and after 18 days of Fermotein™ or control product consumption)
研究者
Diederik Esser
Principle Investigator
Wageningen University and Research