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| Name | Class |
|---|---|
| The Protein Brewery | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermotein™ | Experimental | daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger |
|
| Matched control products | Active Comparator | daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermotein based meals | Other | various meal products: bread, soup and an occasional burgers |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastro intestinal (GI) complaints | 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. | Daily, during 18 days of Fermotein™ intake and up to three days after intake. |
| Measure | Description | Time Frame |
|---|---|---|
| change in blood hemoglobin | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood Fe (iron) | under fasting conditions |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diederik Esser, PhD | Wageningen University and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Wageningen Research | Wageningen | Gelderland | 6708 WG | Netherlands |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Matching control meals with whey protein and wheat bran |
| Other |
various meal products: bread, soup and an occasional burgers |
|
| at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood ferritin | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood insulin | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood glucose | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood cholesterol (total) | under fasting conditions | before and after 18 days consumption of Fermotein™ or control product |
| change in blood ALAT | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood ASAT | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood GGT | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood leukocyte cell counts | under fasting conditions | at baseline, and after 18 days of fermotein or control product consumption |
| change in blood creatinine | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood zonulin | under fasting conditions | at baseline, and after 18 days of Fermotein™ or control product consumption |
| change in blood pressure | systolic and diastolic bloodpressure | at baseline, and after 18 days of Fermotein™ or control product consumption |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |