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

Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals

The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Whey Protein (WPC) at breakfast; Dietary supplement: Other Protein Sources at breakfast; Dietary supplement: Low Protein at breakfast

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • N/A = Not Applicable
    • Holon, N/A = Not Applicable, Israel, 58100
      • Daniela Jakubowicz
• Venezuela
  • N/A = Not Applicable
    • Caracas, N/A = Not Applicable, Venezuela, 410
      • Daniela Jakubowicz MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: CBdiet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 month
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	3 months

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Collaborators: Hospital de Clinicas Caracas

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 diabetes (T2D); Whey Protein Concentrate (WPC)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HCCCBI 057-2011-165