Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tel Aviv University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Fasting circulating levels of HbA1c
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes patients
- •HbA1C > 7.5%
- •Duration of diabetes: < 20 years
- •Subjects ≥ 30 and ≤70 years of age
- •BMI: 22 to 35 kg/m2
- •All oral antidiabetic treatments will be allowed. No insulin
- •Normal liver and kidney function
- •Normal thyroid function
- •Stable physical activity pattern during the three months immediately preceding study
- •No metabolic disease other than diabetes
- •Normal TSH and FT4 levels
- •Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
- •Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria
- •Type 1 diabetes
- •Treatment with Insulin
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- •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)
- •Pregnancy or lactation
- •Illicit drug abuse or alcoholism
- •Subjects taking anoretic drugs during the month immediately prior to study
- •Subjects on steroid treatment
- •Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
- •Those with eating disorders
- •Known hypersensitivity to milk components
- •Subjects after bariatric surgery, will be excluded
- •Subjects known by the principal investigator to be unable to cooperate for any reason.
Arms & Interventions
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.
Intervention: Whey Protein (WPC) at breakfast (Dietary Supplement)
Other Protein Sources at breakfast
The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
Intervention: Other Protein Sources at breakfast (Dietary Supplement)
Low Protein at breakfast
The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
Intervention: Low Protein at breakfast (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Body Weight(3 months)
- Postprandial Glucose(3 month)
Investigators
Daniela Jakubowicz
Prof. Daniela Jakubowicz MD
Hospital de Clinicas Caracas