The Effect of Protein Quality and Time-factor by Consumption of a Pre-meal on Postprandial Lipemia in Subjects With the Metabolic Syndrome.

NCT02228252 | Completed DMC

• 1 other identifier: CERN-Premeal2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 of protein quality and the time factor of protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48). 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 compared to casein protein and gluten protein consumed 15 minutes prior to the meal and whey protein consumed 30 minutes prior to the meal in subjects with MeS. 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.

Conditions

Metabolic Syndrome

Keywords

Proteins; Postprandial lipemia; Pre-meal; Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• Effect on triglyceride response of whey protein as pre-meal after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min).

  Prior to the pre meal (-30/-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 subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min).

  Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.

Secondary Outcomes (5)

• Glucose responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -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 -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -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 -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -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 -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -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 -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -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 Outcomes (8)

• Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)

  Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.

• Change in amino acids concentration from baseline to 30 min

  Baseline (-30/-15 min), 30 min

• Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -30-15 - 360 min)

  Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.

Study Arms (4)

20 g whey protein (-15 min)

EXPERIMENTAL

20 g whey protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.

Other: Whey protein

20 g whey protein (-30 min)

EXPERIMENTAL

20 g whey protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 30 min prior to the main meal.

Other: Whey protein

20 g casein

EXPERIMENTAL

20 g casein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.

Other: Casein

20 g gluten protein

EXPERIMENTAL

21.5 g gluten protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.

Other: Gluten protein

Interventions

Whey protein OTHER

Also known as: Brand name: LACPRODAN® SP-9225 Instant, Lot nr.: D150214

20 g whey protein (-15 min); 20 g whey protein (-30 min)

Casein OTHER

Also known as: Brand name: MIPRODAN 30, Lot nr.: 1594303

20 g casein

Gluten protein OTHER

Also known as: Brand name: Reppe wheat gluten

20 g gluten protein

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Central obesity (female \> 80 cm; male \> 94 cm) with two of the following parameters:
• Fasting triglycerides \> 1.7 mmol/L
• Fasting HDL-cholesterol \< 1.03 mmol/L (female) or \<1.29 mmol/L (male)
• Blood pressure ≥ 130/85 mmHg
• Fasting plasma glucose ≥ 5.6 mmol/L Subjects who are in medical treatment with lipid and/or blood pressure-lowering habitual treatment can participate provided that the treatment is stable throughout the trial.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Whey Proteins; Caseins; Glutens

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic 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; Phosphoproteins; Prolamins; Grain Proteins; Plant Proteins; Seed Storage Proteins

Study Officials

• Kjeld Hermansen, Prefessor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2014-08

Locations

DK (1)