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Effects of Whey Protein in Type 2 Diabetics (WHEY-T2D)

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ClinicalTrials.gov Identifier: NCT01944449
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Hospital de Clinicas Caracas
Information provided by (Responsible Party):
Daniela Jakubowicz, Hospital de Clinicas Caracas

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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Whey Protein (WPC) at breakfast Dietary Supplement: Other Protein Sources at breakfast Dietary Supplement: Low Protein at breakfast Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
Actual Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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 Name: WBdiet

Experimental: Other Protein Sources at breakfast
The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
Dietary Supplement: 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.
Other Name: PBdiet

Active Comparator: Low Protein at breakfast
The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
Dietary Supplement: 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 Name: CBdiet




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Postprandial Glucose [ Time Frame: 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

  2. Body Weight [ Time Frame: 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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944449


Locations
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Israel
Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel, 58100
Venezuela
Daniela Jakubowicz MD
Caracas, N/A = Not Applicable, Venezuela, 410
Sponsors and Collaborators
Tel Aviv University
Hospital de Clinicas Caracas
Investigators
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Principal Investigator: Julio Wainstein, MD Head of Diabetes Unit E. Wolfson Medical Center Israel
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas, Venezuela

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Responsible Party: Daniela Jakubowicz, Prof. Daniela Jakubowicz MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier: NCT01944449     History of Changes
Other Study ID Numbers: HCCCBI 057-2011-165
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: January 2016

Keywords provided by Daniela Jakubowicz, Hospital de Clinicas Caracas:
Type 2 diabetes (T2D)
Whey Protein Concentrate (WPC)

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases