Clinical trial NCT01944449: Effects of Whey Protein in Type 2 Diabetics
Official title: Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes (T2D)
Whey Protein Concentrate (WPC)
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas Caracas
First posted: 2013-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting circulating levels of HbA1c
timeFrame: 3 month
Secondary outcomes:
measure: Postprandial Glucose
timeFrame: 3 month
measure: Body Weight
timeFrame: 3 months
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Daniela Jakubowicz
state: N/A = Not Applicable
city: Caracas
country: Venezuela
facility: Daniela Jakubowicz MD
state: N/A = Not Applicable
Study officials:
affiliation: Head of Diabetes Unit E. Wolfson Medical Center Israel
name: Julio Wainstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas Caracas, Venezuela
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: