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Completed

NCT Number: NCT03620812

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.

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Key information

Conditions

Health, Subjective

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martin-Luther-University Institute of Agriculture and Nutritional Science

Halle, Saxony-Anhalt, 06120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rapeseed or soy protein or no protein

Dietary Supplement

25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day

Primary outcomes

  1. time course of glucose level

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial blood glucose level

Secondary outcomes

  1. Cholesterol

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of Cholesterol

  2. triglycerides

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of triglycerides

  3. short chain fatty acids

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of short chain fatty acids

  4. indole-3-propionate

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of indole-3-propionate

  5. amino acids

    Time frame: 0,15,30,45,60,90,120 and 180 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of amino acids

  6. hormones (insulin, ghrelin, FGF23)

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of hormones (insulin, ghrelin, FGF23)

  7. time course of urea level,

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of urea

  8. minerals and blood hsCRP

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    Impact of rapeseed protein on the postprandial levels of minerals and blood hsCRP

  9. systolic and diastolic blood pressures

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    time course: measurement of blood pressure in mm Hg

  10. feeling of satiety by means of a questionnaire

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

  11. heart rate

    Time frame: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat

    time course: measurement of heart rate in beats per minute

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • UFOP Union for the promotion of oil and protein plants eV
  • University of Halle Medical Faculty

Registry information

Official study title

Influence of Rapeseed Proteins on the Postprandial Metabolic Response.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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