Focus on the results of Pep2Dia® preclinical and clinical studies

HomeBioactive Pep2Dia®Pre-clinical and clinical studies

Measuring, analysing and optimising the effectiveness of a bioactive before it is put on the market requires running preclinical and clinical studies.

It was after three years of research and testing carried out in collaboration with several laboratories that the Pep2Dia®bioactive was created, an innovative ingredient in the regulation of blood sugar.

Clinical and preclinical studies in collaboration with various partners

All of the steps leading to the development and testing of bioactive Pep2Dia® are the result of close collaboration between several partners: La Rochelle University, the LIENSs laboratory and the Ingredia company.

CNRS’s LIENSs laboratory (Littoral ENvironnement et Sociétés) is an interdisciplinary research unit working with La Rochelle University on the challenges of sustainable development in connection with the coast. It integrates the skills of many disciplines ranging from environmental sciences to humanities, but also includes chemistry and biotechnology.

« 700 million people will be diabetic in 2045 »
– www.idf.org : Diabetes facts & figures

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.

Clinical study results - Phase I

In fact, Pep2Dia® reduces blood sugar levels by 21% after a sweet meal in people with prediabetes.

Pep2Dia® also works by lowering the maximum blood sugar level after a meal high in sugar (-7% on the peak in blood sugar and -16% on the maximum increase in glucose compared to a placebo). In addition, Pep2Dia® does not increase insulin levels, which is important for people with prediabetes who have a tendency for hypersecretion of insulin.

Clinical study results - Phase II

Finally, the results show that Pep2Dia® significantly decreases the level of glycated haemoglobin (HbA1c which characterises the history of blood sugar levels over the past three months), the main factor in detecting hyperglycaemia and the main symptom of prediabetes, after six weeks of supplementation.

In summary, bioactive Pep2Dia® acts on the main factors inducing diabetes and helps prediabetics to improve their health.

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