Influence of Rapeseed Proteins on the Postprandial Metabolic Response

Influence of Rapeseed Proteins on the Postprandial Metabolic Response.

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.

Study Overview

• Status: Completed
• Conditions: Health, Subjective
• Intervention / Treatment: Dietary supplement: rapeseed or soy protein or no protein

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony Anhalt
    • Halle, Saxony Anhalt, Germany, 06120
      • Martin-Luther-University Institute of Agriculture and Nutritional Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rapeseed protein; 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; 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day
Active Comparator: soy protein	Dietary supplement: rapeseed or soy protein or no protein; 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day
Placebo Comparator: no protein	Dietary supplement: rapeseed or soy protein or no protein; 25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Collaborators: University of Halle Medical Faculty; UFOP Union for the promotion of oil and protein plants eV
• Investigators: Study Director: Gabriele Stangl, Prof.Dr., MLU, Institut für Agrar-und Ernährungswissenschaften

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): April 6, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: rapeseed, protein, postprandial, glucose
• Other Study ID Numbers: UFOP 062018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No