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PRIME study

Postprandial Regulation Involving Metabolic Effects of Fermofine - the short term effects of Fermofine on blood glucose responses - PRIME study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58382
Enrollment
28
Registered
2025-12-04
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postprandial glycemic responses Aftermeal blood sugar responses

Interventions

a carbohydrate-rich fruit smoothie containing either 0, 21 or 42 grams of Fermofine

Sponsors

The Protein Brewery
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 50-80yrs BMI >25 kg/m2 Having veins suitable for blood sampling via a catheter Having one or more of the following criteria:HbA1c> 5.7% Fasting glucose >5.6mmol/LTwo-hour glucose levels >7.8 mmol/L on the 75-g oral glucose tolerance test

Exclusion criteria

Exclusion criteria: Having a disease that may interfere with the outcomes of the study, such as a known metabolic, gastrointestinal, inflammatory or chronic disease as judged by the medical supervisorHaving a history of medical or surgical events that may significantly affect the study outcome, as judged by the medical supervisor (medical investigator) Use of medication that may interfere with the study outcomes, such as medication known to affect glucose homeostasis (as judged by medical investigator) Reported to follow or having planned a slimming or medically prescribed diet; Reported weight loss or weight gain of more than 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period; Recent blood donation (<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study Current smokers, or stopped smoking in the last 3 months before study startAverage alcohol intake >21 (women) or >28 (men) glasses of alcoholic beverages per week Use of drugs Food allergies for products that we use in the study including fungiParticipation in any other clinical trial including blood sampling and/or administration of substances up to 30 days before test day 1 of this study and during the study periodBeing an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research.  

Design outcomes

Primary

MeasureTime frame
Postprandial glucose (PPG) response (incremental area under the curve) 

Secondary

MeasureTime frame
Time to peak and maximum peak height of postprandial blood glucose responses Incremental area under the curve, time to peak and maximum peak height of postprandial insulin responses

Countries

Netherlands

Contacts

Public ContactS Haar

Wageningen Universiteit

yvonnedommels@theproteinbrewery.nl076 209 1000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026