Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This study evaluates the effect in HbA1c levels of a once daily administration of plant-based
      hydrolysates in pre-diabetic, but otherwise healthy volunteers. Among the 63 subjects
      enrolled, 21 will receive a plant-based hydrolysates from one cereal, 21 will receive a
      plant-based hydrolysates from another cereal and 21 will receive a placebo.
    

Detailed description: 
      Pre-clinical data on human skeletal muscle cells and mouse Type 2 diabetes model have shown a
      blood glucose lowering effect of the plant-based hydrolysates.

      The first objective of the study is to evaluate the effect of a once daily administration of
      2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week period,
      at reducing the preferred outcome measure identified by the European Food Safety Authority
      i.e. glycated haemoglobin (HbA1c) levels in pre-diabetic volunteers who are otherwise healthy
      subjects.

      The second objective of the study is to evaluate the effect of a fixed daily administration
      of 2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week
      period on further supportive measures like Post-prandial glucose/insulin levels, fructosamine
      level, fasting plasma glucose level, vital signs and blood pressure, weight and BMI.
    

Intervention name(s): 12 weeks daily administration Cereal 1; 12 weeks daily administration Cereal 2; 12 weeks daily administration Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product.
Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
The daily dose administrated is 15 grams.; The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product.
Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
The daily dose administrated is 15 grams.; The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of placebo.
Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment