Tolerase® G: benefits, dosage, contraindications

Updated on 19 March 2025

Tolerase® G, a specific proline endopeptidase or prolyl-oligopeptidase, is a dietary enzyme scientifically proven to help break down gluten in the stomach. Tolerase® G - or Aspergillus Niger-Prolyl Endopeptidase - is derived from the food-grade fungus Aspergillus niger. It is marketed by DSM. Tolerase® G is designed for gluten intolerances, it specifically degrades the immunogenic parts of gluten proteins, and is stable and active under gastric conditions.

Other name(s)

Aspergillus Niger-Prolyl Endopeptidase

Scientific name(s)

prolyl-oligopeptidase

Family or group:

Enzymes

Indications

Rating methodology

EFSA approval.

Several clinical trials (> 2) randomized controlled with double blind, including a significant number of patients (>100) with consistently positive outcomes for the indication.

Several clinical trials (> 2) randomized controlled with double blind, and including a significant number of patients (>100) with positive outcomes for the indication.

One or more randomized studies or multiple cohorts or epidemiological studies with positive outcomes for the indication.

Clinical studies exist but are uncontrolled, with conclusions that may be positive or contradictory.

Lack of clinical studies to date that can demonstrate the indication.

Gluten intolerance
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The enzyme is capable of fully breaking down all gluten epitopes (gliadin and glutenin), both in the stomach and the small intestine. Tolerase®-G has optimal activity at a pH of 4-5 and remains stable at a pH of 2. The enzyme is fully resistant to pepsin in gastric juice.

Posologie

Oral administration

40 PPU

A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet
Highly efficient gluten degradation with a newly identified prolyl endoprotease: implications for celiac disease
Efficient degradation of gluten by a prolyl endoprotease in a gastrointestinal model: implications for coeliac disease
Randomised clinical study: Aspergillus niger-derived enzyme digests gluten in the stomach of healthy volunteers

Properties

Safety dosage

Adult: 40 PPU - 120 PPU

EFSA: Tolerase® G is intended to be consumed just before, during, or directly after a meal. The recommended dose is 40 PPU of Tolerase® G per meal (= 0.916 g of enzyme preparation) and a maximum daily intake of 120 PPU (2x10E6 PPI) of Tolerase® G (approximately 2.7 g of enzyme preparation), which would correspond to three intakes (three meals) per day.

Conseil scientifique

Tolerase® G: benefits, dosage, contraindications

Indications

Gluten intolerance ✪✪✪✪✪

Properties

Safety dosage

Gluten intolerance
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