Effects of Whey Protein in Type 2 Diabetics

N/ACompletedNCT01944449

Tel Aviv University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Whey Protein (WPC) at breakfastDIETARY_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.

Other Protein Sources at breakfastDIETARY_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 breakfastDIETARY_SUPPLEMENT

The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Type 2 diabetes patients 2. HbA1C \> 7.5% 3. Duration of diabetes: \< 20 years 4. Subjects ≥ 30 and ≤70 years of age 5. BMI: 22 to 35 kg/m2 6. All oral antidiabetic treatments will be allowed. No insulin 7. Normal liver and kidney function 8. Normal thyroid function 9. Stable physical activity pattern during the three months immediately preceding study 10. No metabolic disease other than diabetes 11. Normal TSH and FT4 levels 12. Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests 13. Read and understood the informed consent form and signed it voluntarily Exclusion Criteria: 1. Type 1 diabetes 2. Treatment with Insulin 3. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease 4. 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) 5. Pregnancy or lactation 6. Illicit drug abuse or alcoholism 7. Subjects taking anoretic drugs during the month immediately prior to study 8. Subjects on steroid treatment 9. Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases, 10. Those with eating disorders 11. Known hypersensitivity to milk components 12. Subjects after bariatric surgery, will be excluded 13. Subjects known by the principal investigator to be unable to cooperate for any reason.

Locations (2)

Daniela Jakubowicz

Holon, N/A = Not Applicable, Israel

Daniela Jakubowicz MD

Caracas, N/A = Not Applicable, Venezuela

Outcomes

Primary Outcomes

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.

Time frame: 3 month

Secondary Outcomes

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

Time frame: 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

Time frame: 3 months

Data from ClinicalTrials.gov

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