Effects of Whey Protein in Type 2 Diabetics

NCT01944449 | Completed DMC

• 1 other identifier: HCCCBI 057-2011-165
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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).

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes (T2D); Whey Protein Concentrate (WPC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postprandial Glucose

  3 month

• Body Weight

  3 months

Study Arms (3)

Whey Protein (WPC) at breakfast

EXPERIMENTAL

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

Other Protein Sources at breakfast

EXPERIMENTAL

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

Dietary Supplement: Other Protein Sources at breakfast

Low Protein at breakfast

ACTIVE COMPARATOR

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

Dietary Supplement: Low Protein at breakfast

Interventions

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.

Also known as: WBdiet

Whey Protein (WPC) at breakfast

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.

Also known as: PBdiet

Other Protein Sources at breakfast

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.

Also known as: CBdiet

Low Protein at breakfast

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead
• Hospital de Clinicas Caracas: collaborator

Study Sites (2)

Daniela Jakubowicz

Holon, N/A = Not Applicable, 58100, Israel

Location

Daniela Jakubowicz MD

Caracas, N/A = Not Applicable, 410, Venezuela

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Julio Wainstein, MD

  Head of Diabetes Unit E. Wolfson Medical Center Israel

  PRINCIPAL INVESTIGATOR

• Daniela Jakubowicz, MD

  Hospital de Clinicas Caracas, Venezuela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Daniela Jakubowicz MD

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 11, 2017

Record last verified: 2016-01

Locations

VE (1); IL (1)