Influence of Rapeseed Proteins on the Postprandial Metabolic Response

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of rapeseed proteins on the postprandial metabolic response. Therefore, study participants will receive a meal rich in fat and carbohydrates with and without rapeseed protein or with soy protein that serves as control.

Detailed Description
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The current study is a monocentric, controlled intervention study that will be conducted as cross-over design. Three interventions are planned and participants will be invited to consume a test meal with added rapeseed protein isolate, a test meal with added soy protein isolate and a test meal without additional protein. The evening before, the subjects will receive a standardized dinner. After a 12-hour fasting overnight, a cannula will be placed. Blood samples will be taken before and after eating the test meal rich in carbohydrate and fat. The test meal consists of pasta with oily tomato sauce with either 25 g of rapeseed protein, 25 g of soy protein or no additional protein. A total of 11 blood samples will be collected over a period of 6 hours. In the meantime, the blood pressure and pulse will be measured repeatedly and information on satiety will be recorded. The interventions will be interrupted by a period of, at least, 2 weeks.

Official Title
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Influence of Rapeseed Proteins on the Postprandial Metabolic Response.

Conditions
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Health, Subjective

Intervention / Treatment
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* Dietary Supplement: rapeseed or soy protein or no protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy men and women age between 18 and 65 years informed consent body mass index between 18,5 up to 29,9 kg/m2 anamnesis without diagnostic findings Exclusion Criteria: acute or chronic diseases ((hypertension, coronary diseases, renal diseases, diabetes, alcohol abuse etc.) intake of drugs (exemption: oral contraceptive) pregnancy or lactation food intolerance or allergies to mustard, soy, tomato, wheat participation on another trial blood donation - while last 2 month before the start of the study extensive physical activity (competitive sports, hard physical work) diet procedure smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rapeseed protein<br>Three interventions are planned, in which the subjects will eat a test meal with added rape protein isolate (arm 1), a test meal with added soy protein isolate (arm 2) and a test meal without additional protein (arm 3) in random order on 3 days. The subjects are randomly assigned to one of the 3 treatment arms, ultimately resulting in 6 sequences (cross-over) | Dietary Supplement: rapeseed or soy protein or no protein<br>* 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day<br>|
| Active Comparator: soy protein<br> | Dietary Supplement: rapeseed or soy protein or no protein<br>* 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day<br>|
| Placebo Comparator: no protein<br> | Dietary Supplement: rapeseed or soy protein or no protein<br>* 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time course of glucose level | Impact of rapeseed protein on the postprandial blood glucose level | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol | Impact of rapeseed protein on the postprandial levels of Cholesterol | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| triglycerides | Impact of rapeseed protein on the postprandial levels of triglycerides | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| short chain fatty acids | Impact of rapeseed protein on the postprandial levels of short chain fatty acids | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| indole-3-propionate | Impact of rapeseed protein on the postprandial levels of indole-3-propionate | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| amino acids | Impact of rapeseed protein on the postprandial levels of amino acids | 0,15,30,45,60,90,120 and 180 min after ingestion of testmeal rich in carbohydrates and fat | 
| hormones (insulin, ghrelin, FGF23) | Impact of rapeseed protein on the postprandial levels of hormones (insulin, ghrelin, FGF23) | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| time course of urea level, | Impact of rapeseed protein on the postprandial levels of urea | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| minerals and blood hsCRP | Impact of rapeseed protein on the postprandial levels of minerals and blood hsCRP | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| systolic and diastolic blood pressures | time course: measurement of blood pressure in mm Hg | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| feeling of satiety by means of a questionnaire |  | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 
| heart rate | time course: measurement of heart rate in beats per minute | 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rapeseed, protein, postprandial, glucose