The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes

NCT02343471 | Completed DMC

• 1 other identifier: CERN-Premeal3
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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 whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects with type 2 diabetes compared to healthy subjects. 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 in type 2 diabetic subjects compared to healthy subjects. 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

Healthy; Type 2 Diabetes

Keywords

Whey proteins; Postprandial lipemia; Pre-meal; Type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Effect on triglyceride response of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes 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

• Effect on apolipoprotein B48 of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes 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)

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

• Change in amino acids concentration from baseline to 360 min

  Baseline (-15 min), 30, 180 and 360 min

• Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -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

Study Arms (2)

20 g whey protein

EXPERIMENTAL

20 g whey protein dissolved in 200 milliliter (mL) water is consumed as a pre-meal 15 min prior to the main meal. Additionally, 200 mL water is consumed as a part of the main meal.

Dietary Supplement: 20 g whey protein

Water

PLACEBO COMPARATOR

200 milliliter (mL) water consumed as pre-meal 15 min prior to the main meal. 20 g whey protein dissolved in 200 mL water is consumed as a part of the main meal.

Dietary Supplement: 20 g whey protein

Interventions

20 g whey protein DIETARY_SUPPLEMENT

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

20 g whey protein; Water

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight stable for the last three month.
• BMI\<40
• Diagnosed type 2 diabetes (HbA1c \> 48 mmol/l)
• Stable dose of Metformin, Sulfonylurea (SU), insulin and SGLT inhibitors are accepted.

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
• Treatment with DPP-4 inhibitors, GLP-1 agonists and basal bolus insulin.
• Fasting blood glucose ≥ 14 mmol/l.
• Prediabetes, defined from the WHO criteria (IGF ≥ 6.1 mmol/l).

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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, 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: January 16, 2015
• First Posted: January 22, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-01