Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome

NCT ID: NCT02087124

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-06-30

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 if there is a dose-response effect of whey 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 (10 or 20g) consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a dose-dependent way compared to placebo (water) consumed 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.

Detailed Description

Using a randomised, cross-over design 20 subjects with MeS will consume a test meal prior to a fat-rich meal. The test meals contain three different amounts of whey protein. 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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

0g whey protein

0g whey protein dissolved in 200 milliliter (mL) water.

Group Type: EXPERIMENTAL

Whey protein

Intervention Type: OTHER

Different amounts of whey protein dissolved in 200 mL water.

10g whey protein

10g whey protein dissolved in 200 milliliter (mL) water.

Group Type: EXPERIMENTAL

Whey protein

Intervention Type: OTHER

Different amounts of whey protein dissolved in 200 mL water.

20g whey protein

20g whey protein dissolved in 200 milliliter (mL) water.

Group Type: EXPERIMENTAL

Whey protein

Intervention Type: OTHER

Different amounts of whey protein dissolved in 200 mL water.

Interventions

Whey protein

Different amounts of whey protein dissolved in 200 mL water.

Intervention Type: OTHER

Other Intervention Names

Brand name: LACPRODAN® SP-9225 Instant; Lot nr.: D150214

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ann Overgaard

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjeld Hermansen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Aarhus C., Denmark

Countries

Denmark

Other Identifiers

CERN-Premeal1

Identifier Type: -

Identifier Source: org_study_id