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Completed

NCT Number: NCT01944449

Effects of Whey Protein in Type 2 Diabetics

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

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daniela Jakubowicz, Holon, N/A = Not Applicable, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whey Protein (WPC) at breakfast

Dietary Supplement

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

Other Protein Sources at breakfast

Dietary Supplement

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

Low Protein at breakfast

Dietary Supplement

The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.

Other names: CBdiet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Hospital de Clinicas Caracas

Registry information

Official study title

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

Acronym: WHEY-T2D

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2013
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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