Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2013-09-30
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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 subjects will consume also 42 g protein at breakfast but from different source, 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 subjects will consume 17 g protein breakfast namely from soy 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
70 Years
ALL
No
Sponsors
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Hospital de Clinicas Caracas
OTHER
Tel Aviv University
OTHER
Responsible Party
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Daniela Jakubowicz
Prof. Daniela Jakubowicz MD
Principal Investigators
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Julio Wainstein, MD
Role: PRINCIPAL_INVESTIGATOR
Head of Diabetes Unit E. Wolfson Medical Center Israel
Daniela Jakubowicz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas Caracas, Venezuela
Locations
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Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel
Daniela Jakubowicz MD
Caracas, N/A = Not Applicable, Venezuela
Countries
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Other Identifiers
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HCCCBI 057-2011-165
Identifier Type: -
Identifier Source: org_study_id