NCT01571622

Brief Summary

The aim of the present study is to examine the therapeutic effect of whey protein concentrate (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP and GLP-1, and DPP-4 plasma levels will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

April 3, 2012

Last Update Submit

March 27, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Whey proteintype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose response

    In all 25 subjects, the effects of whey protein ingestion posprandial glucose, will be measured. Thirty minutes prior to breakfast, subjects will preloaded with one of 2 alternatives: 1. (250 ml) water 2. Whey Protein Concentrate (WPC 80 %), 45 gr dissolved in 250 ml of water

    During 4 hours meal challenge

Secondary Outcomes (1)

  • Insulin GLP-1, GIP and DPP4

    During 4 hours after meal challange

Study Arms (2)

Water before breakfast

PLACEBO COMPARATOR

Each patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with 250 ml of water

Dietary Supplement: Whey before BreakfastDietary Supplement: Water before breakfast

Whey before breakfast

EXPERIMENTAL

Each patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with Whey Protein Concentrate (WPC 80 %) 45 gr dissolved in 250 ml of water\\

Dietary Supplement: Whey before BreakfastDietary Supplement: Water before breakfast

Interventions

Whey before BreakfastDIETARY_SUPPLEMENT

After consumption of whey before breakfast samples will be taken every 30 minutes for quantification of glucose, insulin, GlP-1 and GIP

Water before breakfastWhey before breakfast
Water before breakfastDIETARY_SUPPLEMENT

After water before breakfast the blood samples will be taken every 30 min for quantification of glucose, insulin, GLP-1 and GIP,

Water before breakfastWhey before breakfast

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients
  • Duration of diabetes: 1-10 years
  • Subjects ≥ 40 and ≤70 years of age
  • Metformin therapy and all oral antidiabetic medication will be allowed
  • Overweight or obese (BMI: 25 to 35 kg/m2)
  • Normal liver and kidney function
  • Normal thyroid function
  • Read and understood the informed consent form and signed it voluntarily

You may not qualify if:

  • Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
  • Type 1 or insulin treated diabetes.
  • Pregnancy or lactation
  • Illicit drug abuse or alcoholism
  • Subject treated with insulin or treatment with degradation-resistant GLP-1R agonists (Exendin-4) or similar and DPP4 inhibitors (Januvia)
  • Subjects taking anoretic drugs
  • Subjects on steroid treatment
  • Subjects known by the principal investigator to be unable to cooperate for any reason.
  • Known hypersensitivity to milk components
  • Subjects after bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Unit E. Wolfson Hospital

Holon, Tel Aviv, 58100, Israel

Location

Related Publications (1)

  • Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, Bar-Dayan Y, Ganz T, Barnea M, Wainstein J. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia. 2014 Sep;57(9):1807-11. doi: 10.1007/s00125-014-3305-x. Epub 2014 Jul 10.

    PMID: 25005331DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daniela Jakubowicz, MD

    Diabetes Unit E. Wolfson Medical Center Tel Aviv University

    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
Professor Daniela Jakubowicz MD

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

IL(1)