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

Aarhus University Hospital

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT02087124

CERN-Premeal1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

0g whey protein

Experimental group

Description:

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

Treatment:

Other: Whey protein

10g whey protein

Experimental group

Description:

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

Treatment:

Other: Whey protein

20g whey protein

Experimental group

Description:

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

Treatment:

Other: Whey protein