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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

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE September 17, 2013
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE September 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Fasting circulating levels of HbA1c [ Time Frame: 3 month ]
In all 82 subjects we will evaluate at baseline and after three month of consumption of Whey protein concentrate (WPC) or gluten protein as matched placebo (GLT) the effects on fasting circulating levels of HbA1c.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Postprandial glucose,insulin lipids, and GLP-1 plasma levels [ Time Frame: three months ]
In all 82 subjects we will evaluate at baseline and after three month of consumption of Whey protein concentrate (WPC) or gluten protein as matched placebo (GLT) the effects on 4 hours postprandial responses of plasma glucose, insulin, C-peptide, lipids and GLP-1 levels. During this meal test the samples will be taken at fast and after every 1 hour until 4 hours after breakfast.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 16, 2013)
  • Morning Blood pressure and 24 hours blood pressure(BP) with Holter monitor at baseline and after three month either of supplementation [ Time Frame: Morning BP and 24 hours BP with Holter monitor will be evaluate at baseline and after three month of supplementation with WPC or GLT ]
    In all 82 subjects we will evaluate at baseline and after three month of consumption of Whey protein concentrate (WPC) or gluten protein as matched placebo (GLT) the effects on morning BP pressure and 24 hours BP measured with Holter monitor
  • Circulating Angiotensin II (Ang II) and Angiotensin 1-7 (Ang 1-7) [ Time Frame: 3 months ]
    In all 82 subjects we will evaluate at baseline and after three months of consumption of Whey protein concentrate (WPC) or gluten protein as matched placebo the fasting fasting circulating levels of Ang II and Ang 1-7
 
Descriptive Information
Brief Title  ICMJE Effects of Whey Protein in Type 2 Diabetics
Official Title  ICMJE Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Whey Protein (WPC) at breakfast
  • Experimental: Other Protein Sources at breakfast
    The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
    Intervention: Dietary Supplement: Other Protein Sources at breakfast
  • Active Comparator: Low Protein at breakfast
    The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
    Intervention: Dietary Supplement: Low Protein at breakfast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2013)
82
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01944449
Other Study ID Numbers  ICMJE HCCCBI 057-2011-165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Jakubowicz, Hospital de Clinicas Caracas
Study Sponsor  ICMJE Tel Aviv University
Collaborators  ICMJE Hospital de Clinicas Caracas
Investigators  ICMJE
Principal Investigator: Julio Wainstein, MD Head of Diabetes Unit E. Wolfson Medical Center Israel
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas, Venezuela
PRS Account Tel Aviv University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP