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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Whey Protein (WPC) at breakfast
Other Protein Sources at breakfast
Low Protein at breakfast
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes (T2D), Whey Protein Concentrate (WPC)

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Daniela Jakubowicz
  • Daniela Jakubowicz MD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Whey Protein (WPC) at breakfast

Other Protein Sources at breakfast

Low Protein at breakfast

Arm Description

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.

The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.

The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.

Outcomes

Primary Outcome Measures

Fasting circulating levels of HbA1c
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

Postprandial Glucose
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
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

Full Information

First Posted
September 2, 2013
Last Updated
October 10, 2017
Sponsor
Tel Aviv University
Collaborators
Hospital de Clinicas Caracas
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1. Study Identification

Unique Protocol Identification Number
NCT01944449
Brief Title
Effects of Whey Protein in Type 2 Diabetics
Acronym
WHEY-T2D
Official Title
Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
Collaborators
Hospital de Clinicas Caracas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes (T2D), Whey Protein Concentrate (WPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey Protein (WPC) at breakfast
Arm Type
Experimental
Arm Description
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.
Arm Title
Other Protein Sources at breakfast
Arm Type
Experimental
Arm Description
The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks.
Arm Title
Low Protein at breakfast
Arm Type
Active Comparator
Arm Description
The subjects will consume 17 g protein breakfast namely from soy for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein (WPC) at breakfast
Other Intervention Name(s)
WBdiet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Other Protein Sources at breakfast
Other Intervention Name(s)
PBdiet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Protein at breakfast
Other Intervention Name(s)
CBdiet
Intervention Description
The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.
Primary Outcome Measure Information:
Title
Fasting circulating levels of HbA1c
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Postprandial Glucose
Description
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
Time Frame
3 month
Title
Body Weight
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Wainstein, MD
Organizational Affiliation
Head of Diabetes Unit E. Wolfson Medical Center Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
Hospital de Clinicas Caracas, Venezuela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daniela Jakubowicz
City
Holon
State/Province
N/A = Not Applicable
ZIP/Postal Code
58100
Country
Israel
Facility Name
Daniela Jakubowicz MD
City
Caracas
State/Province
N/A = Not Applicable
ZIP/Postal Code
410
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

Effects of Whey Protein in Type 2 Diabetics

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