Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 760 for:    Area Under Curve AND meal

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

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.


Condition or disease Intervention/treatment Phase
Healthy Type 2 Diabetes Dietary Supplement: 20 g whey protein Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: 20 g whey protein
Other Name: Brand name: LACPRODAN® SP-9225 Instant (Lot nr.: D150214)

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.
Dietary Supplement: 20 g whey protein
Other Name: Brand name: LACPRODAN® SP-9225 Instant (Lot nr.: D150214)




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Other Outcome Measures:
  1. 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) ]
  2. Change in amino acids concentration from baseline to 360 min [ Time Frame: Baseline (-15 min), 30, 180 and 360 min ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343471


Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Kjeld Hermansen, Prefessor Aarhus University Hospital

Layout table for additonal information
Responsible Party: Ann Bjørnshave, PhD student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02343471     History of Changes
Other Study ID Numbers: CERN-Premeal3
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: January 2015
Keywords provided by Ann Bjørnshave, Aarhus University Hospital:
Whey proteins
Postprandial lipemia
Pre-meal
Type 2 diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders