Clinical trial NCT03620812: Influence of Rapeseed Proteins on the Postprandial Metabolic Response
Official title: Influence of Rapeseed Proteins on the Postprandial Metabolic Response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Keywords: rapeseed, protein, postprandial, glucose
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: UFOP Union for the promotion of oil and protein plants eV
name: University of Halle Medical Faculty
First posted: 2018-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: time course of glucose level
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
Secondary outcomes:
measure: Cholesterol
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: triglycerides
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: short chain fatty acids
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: indole-3-propionate
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: amino acids
timeFrame: 0,15,30,45,60,90,120 and 180 min after ingestion of testmeal rich in carbohydrates and fat
measure: hormones (insulin, ghrelin, FGF23)
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: time course of urea level,
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: minerals and blood hsCRP
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: systolic and diastolic blood pressures
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: feeling of satiety by means of a questionnaire
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
measure: heart rate
timeFrame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Martin-Luther-University Institute of Agriculture and Nutritional Science
state: Saxony Anhalt
Study officials:
affiliation: MLU, Institut für Agrar-und Ernährungswissenschaften
name: Gabriele Stangl, Prof.Dr.
role: STUDY_DIRECTOR
References: