Effects of Whey Protein in Type 2 Diabetics

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Whey Protein (WPC) at breakfast; Dietary Supplement: Low Protein at breakfast; Dietary Supplement: Other Protein Sources at breakfast

• Registration Number: NCT01944449
• Lead Sponsor: Tel Aviv University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-17
• Status Verified: 2016-01
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whey Protein (WPC) at breakfast	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.
Low Protein at breakfast	Low Protein at breakfast	The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
Other Protein Sources at breakfast	Other Protein Sources at breakfast	The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Fasting circulating levels of HbA1c	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.

Secondary Outcome Measures

Name	Time	Method
Body Weight	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
Postprandial Glucose	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

Trial Locations

Locations (2)

Daniela Jakubowicz MD; 🇻🇪 Caracas, N/A = Not Applicable, Venezuela

Daniela Jakubowicz; 🇮🇱 Holon, N/A = Not Applicable, Israel