Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes (PREMEAL 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343471
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
University of Aarhus
University of Copenhagen
Information provided by (Responsible Party):
Ann Bjørnshave, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2015
First Posted Date  ICMJE January 22, 2015
Last Update Posted Date May 5, 2015
Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2015)
  • Effect on triglyceride response of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes measured as incremental Area Under the Curve (iAUC -15 - 360 min). [ Time Frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal ]
  • Effect on apolipoprotein B48 of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes measured as incremental Area Under the Curve (iAUC -15 - 360 min). [ Time Frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02343471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2015)
  • Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min). [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2015)
  • Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) ]
  • Change in amino acids concentration from baseline to 360 min [ Time Frame: Baseline (-15 min), 30, 180 and 360 min ]
  • Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -15 - 360 min). [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Satiety measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Responses of the inflammatory marker Rantes measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal ]
  • Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in plasma. [ Time Frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal ]
  • Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in urine [ Time Frame: Prior to the pre meal (-15 min), and 120 and 360 min post main meal ]
  • Responses of satiety visual analog scale (VAS) measured as incremental Area Under the Curve (AUC -15 - 360 min) [ Time Frame: Prior to the pre meal (-15 min), prior to the main meal (0 min) and 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 min post main meal ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes
Official Title  ICMJE Whey Protein, Postprandial Lipemia and Cardiovascular Disease: Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipiemia in Subjects With the Metabolic Syndrome and Type 2 Diabetes
Brief Summary

Cardiovascular disease (CVD) is one of the most important and frequent causes of death. Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2 diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal. Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D. Identification of a simple diet-related method will possibly result in reduction of CVD in healthy as well as high-risk subjects.

The aim of this project is to investigate the effect whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects with type 2 diabetes compared to healthy subjects. Secondarily the aim is to study the responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and metabolomics. Also satiety feeling will be measured.

Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects compared to healthy subjects.

The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner. It will promote innovation to the food industry for development and production of healthy food products, which can be applied in the fight against CVD in the background population in general and high-risk people in particular. Thus, the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems.

Detailed Description Using a randomised, cross-over design 12 healthy subjects and 12 subjects with type 2 diabetes will consume a test meal prior to a fat-rich meal. The test meals contain 2 different meal types; on where whey protein is consumed as a pre-meal and another where water is the pre-meal. In the second meal type whey protein is instead consumed as a part of the fat-rich meal. Blood samples are collected before consumption of the pre-meal and after consumption of the fat-rich isocaloric meal during 360 minutes. The fat-rich isocaloric meal is a breakfast containing 1043 kcal (15 E% protein, 65 E% fat and 20 E% carbohydrates). The main-meal is composed of white bread, rye bread, butter, cheese (45 %), salami, egg, bacon, milk (1.5 % fat) and coffee (decaffeinated) and should be consumed over 15 min. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy
  • Type 2 Diabetes
Intervention  ICMJE Dietary Supplement: 20 g whey protein
Other Name: Brand name: LACPRODAN® SP-9225 Instant (Lot nr.: D150214)
Study Arms  ICMJE
  • Experimental: 20 g whey protein
    20 g whey protein dissolved in 200 milliliter (mL) water is consumed as a pre-meal 15 min prior to the main meal. Additionally, 200 mL water is consumed as a part of the main meal.
    Intervention: Dietary Supplement: 20 g whey protein
  • Placebo Comparator: Water
    200 milliliter (mL) water consumed as pre-meal 15 min prior to the main meal. 20 g whey protein dissolved in 200 mL water is consumed as a part of the main meal.
    Intervention: Dietary Supplement: 20 g whey protein
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2015)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2015)
24
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria - general:

  • Weight stable for the last three month.
  • BMI<40

Inclusion Criteria for subjects with type 2 diabetes:

  • Diagnosed type 2 diabetes (HbA1c > 48 mmol/l)
  • Stable dose of Metformin, Sulfonylurea (SU), insulin and SGLT inhibitors are accepted.

Exclusion Criteria - general:

  • Type 1 diabetes
  • Type 2 diabetes (HbA1c ≥ 48 mmol/L)
  • Fasting plasma triglycerides > 5.0 mmol/L
  • Blood pressure > 160/100 mmHg
  • Cardiovascular, liver, kidney or metabolic disease
  • Corticosteroid treatment
  • Pregnancy or lactation
  • Alcohol or drug abuse
  • Legal incapacity

Exclusion Criteria for subjects with type 2 diabetes:

  • Treatment with DPP-4 inhibitors, GLP-1 agonists and basal bolus insulin.
  • Fasting blood glucose ≥ 14 mmol/l.

Exclusion Criteria for healthy subjects:

  • Prediabetes, defined from the WHO criteria (IGF ≥ 6.1 mmol/l).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343471
Other Study ID Numbers  ICMJE CERN-Premeal3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ann Bjørnshave, Aarhus University Hospital
Study Sponsor  ICMJE Aarhus University Hospital
Collaborators  ICMJE
  • University of Aarhus
  • University of Copenhagen
Investigators  ICMJE
Principal Investigator: Kjeld Hermansen, Prefessor Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP