Effects of Whey Protein in Type 2 Diabetics

Type 2 Diabetes Clinical Trial

— WHEY-T2D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944449
• Other study ID #: HCCCBI 057-2011-165
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: October 10, 2017
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
Israel	Daniela Jakubowicz	Holon	N/A = Not Applicable
Venezuela	Daniela Jakubowicz MD	Caracas	N/A = Not Applicable

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Hospital de Clinicas Caracas

Countries where clinical trial is conducted

Israel,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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