Influence of Rapeseed Proteins on the Postprandial Metabolic Response

Sponsor
Martin-Luther-Universität Halle-Wittenberg (Other)
Overall Status
Completed
CT.gov ID
NCT03620812
Collaborator
UFOP Union for the promotion of oil and protein plants eV (Other), University of Halle Medical Faculty (Other)
20
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3
16
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: rapeseed or soy protein or no protein
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Influence of Rapeseed Proteins on the Postprandial Metabolic Response.
Actual Study Start Date :
Aug 16, 2018
Actual Primary Completion Date :
Apr 6, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. time course of glucose level [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 Outcome Measures

  1. Cholesterol [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 [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 [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 [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 [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) [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, [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Martin-Luther-University Institute of Agriculture and Nutritional Science Halle Saxony Anhalt Germany 06120

Sponsors and Collaborators

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

Investigators

  • Study Director: Gabriele Stangl, Prof.Dr., MLU, Institut für Agrar-und Ernährungswissenschaften

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulf Schlegelmilch, Study Coordinator, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT03620812
Other Study ID Numbers:
  • UFOP 062018
First Posted:
Aug 8, 2018
Last Update Posted:
May 19, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ulf Schlegelmilch, Study Coordinator, Martin-Luther-Universität Halle-Wittenberg

Study Results

No Results Posted as of May 19, 2020