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Tolerance of regular meal intake with mycoprotein

Tolerance of regular meal intake with mycoprotein - TOMMY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50091
Enrollment
24
Registered
2020-05-01
Start date
2020-10-12
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overige gezondheids parameters intestinal discomfort and general health

Interventions

Subjects will daily consume a lunch meal containing approximately 11g of Fermotein or control for 18 days.

Sponsors

Bioscienz
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Apparently healthy men and women Age between 18 and 70 years Body mass index (BMI) between 18.5 and 29.9 kg/m2

Exclusion criteria

Exclusion criteria: * Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease) * 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 *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 & Health group of Wageningen Food & Biobased Research

Design outcomes

Primary

MeasureTime frame
The primairy study parameter is frequency and severity of gastro-intestinal complaints.

Secondary

MeasureTime frame
Secondary outcomes are health parameters derived from blood samples taken before and after the intervention.Additional samples (including stool samples) will be collected to enable future measurements when requested by the assessment committee of the novel food dossier

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)