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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02228252
• Date of registration: 27/08/2014
• Prospective Registration: No
• Primary sponsor: Aarhus University Hospital
• Public title: The Effect of Protein Quality and Time-factor by Consumption of a Pre-meal on Postprandial Lipemia in Subjects With the Metabolic Syndrome.
• Scientific 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
• Date of first enrolment: August 2014
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02228252
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Kjeld Hermansen, Prefessor
• Affiliation: Aarhus University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Other: Gluten protein

Other: Whey protein

Other: Casein

Primary Outcome(s)

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

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). [Time Frame: 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.]

Secondary Outcome(s)

Glucose responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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.]

Secondary ID(s)

CERN-Premeal2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Aarhus

University of Copenhagen