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

NCT02087124 | Completed DMC

• 1 other identifier: CERN-Premeal1
• Study Type: interventional
• Target: 20
• 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 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.

Conditions

Metabolic Syndrome

Keywords

Whey protein; Postprandial lipaemia; Pre-meal; Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• Dose-response of whey protein as pre-meal on triglycerides 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 (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.

• Dose-response of whey protein as pre-meal on apolipoprotein B48 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 (-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 -15 - 360 min)

  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)

  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)

  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)

  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)

  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 Outcomes (8)

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

  Prior to the pre meal (-15 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 180, 240 and 360 min post main meal.

• Satiety measured as incremental Area Under the Curve (AUC -15 - 360 min)

  Prior to the pre meal (-15 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 180 and 240min post main meal.

• Change in amino acids concentration from baseline to 30 min

  Baseline (-15 min), 30 min

Study Arms (3)

0g whey protein

EXPERIMENTAL

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

Other: Whey protein

10g whey protein

EXPERIMENTAL

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

Other: Whey protein

20g whey protein

EXPERIMENTAL

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

Other: Whey protein

Interventions

Whey protein OTHER

Different amounts of whey protein dissolved in 200 mL water.

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

0g whey protein; 10g whey protein; 20g whey protein

Eligibility Criteria

• Age: 18 Years - 80 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

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus C., 8000, Denmark

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Whey Proteins

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

Study Officials

• Kjeld Hermansen, Professor

  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: March 10, 2014
• First Posted: March 14, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2014

Record last verified: 2014-03

Locations

DK (1)