Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital de Clinicas Caracas | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey Protein (WPC) at breakfast | Experimental | 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. |
|
| Other Protein Sources at breakfast | Experimental | The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks. |
|
| Low Protein at breakfast | Active Comparator | The subjects will consume 17 g protein breakfast namely from soy for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein (WPC) at breakfast | Dietary Supplement | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julio Wainstein, MD | Head of Diabetes Unit E. Wolfson Medical Center Israel | Principal Investigator |
| Daniela Jakubowicz, MD | Hospital de Clinicas Caracas, Venezuela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniela Jakubowicz | Holon | N/A = Not Applicable | 58100 | Israel | ||
| Daniela Jakubowicz MD |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Other Protein Sources at breakfast | Dietary Supplement | 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. |
|
|
| Low Protein at breakfast | Dietary Supplement | The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks. |
|
|
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 |
| Caracas |
| N/A = Not Applicable |
| 410 |
| Venezuela |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |