Focus on the results of Pep2Dia® preclinical and clinical studies

Ingredia is a subsidiary of the « Prospérité Fermière » dairy cooperative, based in Pas-de-Calais. It specialises in the processing of milk and, in particular, the cracking of milk.

Thanks to its expertise and its partnership with research laboratories, Ingredia produces dairy ingredients and bioactives to promote better human nutrition.

Progress in Pep2Dia® preclinical and clinical studies

Because a bioactive ingredient is an ingredient of food origin that has a natural action on health and is not a simple food (without being a drug), its manufacturing process is based on a set of steps, including several test phases whose role is to validate its effectiveness and the absence of side effects.

Preclinical Pep2Dia®studies

Once the active peptide is identified, AP in the case of Pep2Dia®, the first validation step is completed during in vitro laboratory testing. Once the results were conclusive, the product obtained was produced in a ‘pilot version’. It was only when the search for the active dose was validated that clinical trials were established in 2019 before the final product launch.

Pep2Dia® clinical studies

Ingredia researchers verified the effectiveness of the bioactive in people with prediabetes and then identified the effective dose for humans.

To achieve this, the clinical study was conducted in two phases with people with prediabetes.

The 21 prediabetic volunteers, men and women, were recruited according to specific criteria:

• Aged between 30 and 70,the average age of participants in the study was 62
• A fasting blood sugar level of between 1 and 1.25 g/l and/or a glycated haemoglobin with an HbA1c level between 5.7 and 6.4% (fasting blood sugar is an instantaneous measure of the glycaemic state, while the HbA1c blood test assesses the glycaemic balance over a period of about two to three months)
• A body mass index(BMI) of 19 to 35 kg/m²
• Non-smokers
• Caucasian
• No change in eating habits or physical activity in the three months before screening and during the study
• An absence of exclusionary causes (taking certain medications, certain diseases etc.)

The clinical trial was conducted in two phases.

The first phase was a double-blind randomised crossover study (randomised test product, with neither the patient, researcher nor doctor aware of which product has been administered).

In the trial, the product was given to volunteers 15 minutes before a high-sugar breakfast.

In the second stage of the clinical study, a supplement of 1,400 mg of Pep2Dia® was given for six weeks, before the main meal of the day.

The results of preclinical and clinical Pep2Dia® studies

The preclinical and clinical Pep2Dia® studies have demonstrated a significant reduction in postprandial glycaemia, that is to say a reduction in the blood’s glucose content after meals, and without affecting an increase in the secretion of insulin.