Effects of Whey Protein in Type 2 Diabetics (WHEY-T2D)
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|ClinicalTrials.gov Identifier: NCT01944449|
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Dietary Supplement: Whey Protein (WPC) at breakfast Dietary Supplement: Other Protein Sources at breakfast Dietary Supplement: Low Protein at breakfast||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Whey Protein (WPC) at breakfast
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
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.
Other Name: WBdiet
Experimental: Other Protein Sources at breakfast
The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
Dietary Supplement: Other Protein Sources at breakfast
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.
Other Name: PBdiet
Active Comparator: Low Protein at breakfast
The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
Dietary Supplement: Low Protein at breakfast
The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.
Other Name: CBdiet
- Fasting circulating levels of HbA1c [ Time Frame: 3 month ]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.
- Postprandial Glucose [ Time Frame: 3 month ]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
- Body Weight [ Time Frame: 3 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944449
|Holon, N/A = Not Applicable, Israel, 58100|
|Daniela Jakubowicz MD|
|Caracas, N/A = Not Applicable, Venezuela, 410|
|Principal Investigator:||Julio Wainstein, MD||Head of Diabetes Unit E. Wolfson Medical Center Israel|
|Principal Investigator:||Daniela Jakubowicz, MD||Hospital de Clinicas Caracas, Venezuela|