Effects of Whey Protein in Type 2 Diabetics

Study Overview
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Brief Summary
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The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).

Detailed Description
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Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity, which might be an additional mechanism accounting for the glucose lowering effects of Whey. In the investigators previous study, the acute administration with Whey protein resulted in postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1, suggesting that the peptides generated from Whey protein may have dual beneficial effects (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia regulation in subjects with type 2 diabetes. Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2 diabetic subjects and there are also clinical evidence in non-diabetics individuals, that acute and chronic administration of Whey protein has antihypertensive activity. The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined previously in type 2 diabetics.

Official Title
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Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Whey Protein (WPC) at breakfast
* Dietary Supplement: Other Protein Sources at breakfast
* Dietary Supplement: Low Protein at breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients HbA1C > 7.5% Duration of diabetes: < 20 years Subjects ≥ 30 and ≤70 years of age BMI: 22 to 35 kg/m2 All oral antidiabetic treatments will be allowed. No insulin Normal liver and kidney function Normal thyroid function Stable physical activity pattern during the three months immediately preceding study No metabolic disease other than diabetes Normal TSH and FT4 levels Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests Read and understood the informed consent form and signed it voluntarily Exclusion Criteria: Type 1 diabetes Treatment with Insulin Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) Pregnancy or lactation Illicit drug abuse or alcoholism Subjects taking anoretic drugs during the month immediately prior to study Subjects on steroid treatment Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases, Those with eating disorders Known hypersensitivity to milk components Subjects after bariatric surgery, will be excluded Subjects known by the principal investigator to be unable to cooperate for any reason.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey Protein (WPC) at breakfast<br>The subjects in Whey Protein (WPC) group will consume WPC (35gr) powder in bottles mixed with 250 ml milk, making a total of 42 g protein, at breakfast, for 12 weeks. | Dietary Supplement: Whey Protein (WPC) at breakfast<br>* The type 2 diabetic subjects in Whey Protein (WPC) group will consume at breakfast WPC (35 g) in 250ml of milk, Total 42 g protein breakfast for 12 weeks.<br>* Other names: WBdiet;|
| Experimental: Other Protein Sources at breakfast<br>The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks. | Dietary Supplement: Other Protein Sources at breakfast<br>* The type 2 diabetic subjects in PBdiet will consume also 42 g of protein but from different sources : i.e soy,tuna, eggs, at breakfast in bottle mixed with 250 ml water twice a day (30 min before breakfast and before dinner) for 12 weeks.<br>* Other names: PBdiet;|
| Active Comparator: Low Protein at breakfast<br>The subjects will consume 17 g protein breakfast namely from soy for 12 weeks. | Dietary Supplement: Low Protein at breakfast<br>* The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.<br>* Other names: CBdiet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting circulating levels of HbA1c | In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on fasting circulating levels of HbA1c. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose | In all 60 subjects we will evaluate the effect of consumption of WPC or Protein from other source or Low Protein at breakfast on postprandial glucose | 3 month | 
| Body Weight | In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on body weight | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes (T2D), Whey Protein Concentrate (WPC)