Health, SubjectiveNCT03620812
Influence of Rapeseed Proteins on the Postprandial Metabolic Response
A study testing rapeseed or soy protein or no protein in people with Health, Subjective, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- rapeseed or soy protein or no protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 16 Aug 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- extensive physical activity (competitive sports, hard physical work)
- diet procedure
- smoking
Trial locations and contacts
1 site in 1 country.
Germany1 site
Martin-Luther-University Institute of Agriculture and Nutritional Science
Halle, Saxony-Anhalt, 06120
About this study
Official title: 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.
Read the 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.
- Conditions
- Health, Subjective
- Being tested
- rapeseed or soy protein or no protein
- Keywords
- rapeseed, protein, postprandial, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapeseed or soy protein or no proteinDietary supplement
25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day
| Study group | Role | What they receive |
|---|---|---|
| rapeseed protein | Experimental | 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) Receives: Dietary Supplement: rapeseed or soy protein or no protein |
| soy protein | Active comparator | Not described Receives: Dietary Supplement: rapeseed or soy protein or no protein |
| no protein | Placebo comparator | Not described Receives: Dietary Supplement: rapeseed or soy protein or no protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
time course of glucose level
Impact of rapeseed protein on the postprandial blood glucose level
Measured: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
Secondary outcomes (11)
Cholesterol
Impact of rapeseed protein on the postprandial levels of Cholesterol
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0,15,30,45,60,90,120,180,240,300 and 360 min after ingestion of testmeal rich in carbohydrates and fat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start16 Aug 2018
- Primary completion6 Apr 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- UFOP Union for the promotion of oil and protein plants eV, University of Halle Medical Faculty
- Responsible party
- Principal investigator, Ulf Schlegelmilch, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gabriele Stangl, Prof.Dr., Study director, MLU, Institut für Agrar-und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620812
- Sponsor's protocol ID
- UFOP 062018
- Status last verified
- May 2020
- First submitted
- 26 Jun 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Rapeseed Proteins on the Postprandial Metabolic Response.
- ClinicalTrials.gov ID
- NCT03620812
- Acronym / sponsor ID
- UFOP 062018
- Conditions
- Health, Subjective
- Keywords
- rapeseed, protein, postprandial, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- UFOP Union for the promotion of oil and protein plants eV, University of Halle Medical Faculty
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rapeseed protein | Experimental | Dietary Supplement: rapeseed or soy protein or no proteinThree 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) |
| soy protein | Active comparator | Dietary Supplement: rapeseed or soy protein or no protein |
| no protein | Placebo comparator | Dietary Supplement: rapeseed or soy protein or no protein |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapeseed or soy protein or no protein25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day | Dietary supplement | no protein, rapeseed protein, soy protein |
Primary outcome
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
11 secondary outcomes
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
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
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
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
amino acids
Time frame: 0,15,30,45,60,90,120 and 180 min after ingestion of testmeal rich in carbohydrates and fat
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Stangl, Prof.Dr. study director
MLU, Institut für Agrar-und Ernährungswissenschaften
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapeseed or soy protein or no protein in people with Health, Subjective, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.