Influence of Rapeseed Proteins on the Postprandial Metabolic Response

Health, Subjective Clinical Trial

Official title:

Influence of Rapeseed Proteins on the Postprandial Metabolic Response.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620812
• Other study ID #: UFOP 062018
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Health, Subjective

Intervention

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

Locations

Country	Name	City	State
Germany	Martin-Luther-University Institute of Agriculture and Nutritional Science	Halle	Saxony Anhalt

Sponsors (3)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	UFOP Union for the promotion of oil and protein plants eV, University of Halle Medical Faculty

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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