HypercholesterolemiaNCT01598649
Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
A study testing Fabricated foods with lupin protein, Mannitol and Arginine in people with Hypercholesterolemia, run by University of Jena at 1 site in Germany.
Trial summary
The objective of the study is to elucidate the effects of lupin protein (Lupinus angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Fabricated foods with lupin protein, Mannitol and Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Oct 2013
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate Hypercholesterolemia (total cholesterol >= 5.2 mmol/L)
- Age: 20-80 years
Who cannot join
- Intake of lipid-lowering pharmaceuticals
- Allergy against legumes
- Intolerance or allergy against milk
- Pregnancy, lactation
- Chronic bowel diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia
About this study
Official title: Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
The objective of the study is to elucidate the effects of lupin protein (Lupinus angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein.
Read the detailed description
The study is based on a previous finding that a daily dosage of 25 g lupin protein isolate, administered as protein drinks, is capable to influence the plasma lipids positively.
Consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented daily.
A double-blinded, controlled, randomized cross-over trial will be performed. Altogether 75 volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each. After a run-in period (baseline), the first group will consume foods with lupin protein isolate (group A), the second group will receive the same foods with milk protein isolate (group B) and the third group will consume the foods with milk protein and 1,6 g arginine per day over a period of four weeks. After a wash-out period of six weeks, the diet will be crossed within the three groups for a second intervention period of four weeks. After another wash-out period, diet will be crossed within the three groups once again.
Arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the two groups receiving foods with milk protein. In the other groups (receiving foods with lupin protein or milk protein only) four placebo capsules will be served, containing mannitol.
- Conditions
- Hypercholesterolemia
- Being tested
- Fabricated foods with lupin protein, Mannitol, Arginine, Fabricated foods with milk protein
- Keywords
- Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched foods
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fabricated foods with lupin proteinDietary supplement
- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)
MannitolDietary supplement
- Placebo capsules containing mannitol (four capsules per day)
ArginineDietary supplement
- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)
Fabricated foods with milk proteinDietary supplement
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
| Study group | Role | What they receive |
|---|---|---|
| Lupin protein | Experimental | Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol Receives: Dietary Supplement: Fabricated foods with lupin protein; Dietary Supplement: Mannitol |
| Milk protein | Active comparator | Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules Receives: Dietary Supplement: Mannitol; Dietary Supplement: Fabricated foods with milk protein |
| Milk protein and arginine | Active comparator | Milk Protein Isoalte (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and 1,6 g Arginin in four caspules per day Receives: Dietary Supplement: Arginine; Dietary Supplement: Fabricated foods with milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cholesterol metabolism
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
Measured: After 0, 4, 10, 14, 20, and 24 weeks
Secondary outcomes (4)
Changes in protein metabolism
Plasma: amino acids, total protein, albumin, urea
Measured: After 0,4, 10, 14, 20, and 24 weeks
Changes in body composition (body status)
Bioelectrical impedance analysis, body weight, blood pressure
Measured: After 0, 4, 10, 14, 20, and 24 weeks
Changes in high-sensitive CRP
Inflammation marker
Measured: After 0, 4, 10, 14, 20, and 24 weeks
Changes in parameter of diabetes mellitus
Fasting glucose
Measured: After 0, 4, 10, 14, 20, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598649
- Sponsor's protocol ID
- LSEP H52-12
- Status last verified
- Oct 2013
- First submitted
- 9 May 2012
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bahr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.
PubMed 24746974
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT01598649
- Acronym / sponsor ID
- LSEP H52-12
- Conditions
- Hypercholesterolemia
- Keywords
- Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- 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 objective of the study is to elucidate the effects of lupin protein (Lupinus angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein.
Detailed description
The study is based on a previous finding that a daily dosage of 25 g lupin protein isolate, administered as protein drinks, is capable to influence the plasma lipids positively.
Consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented daily.
A double-blinded, controlled, randomized cross-over trial will be performed. Altogether 75 volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each. After a run-in period (baseline), the first group will consume foods with lupin protein isolate (group A), the second group will receive the same foods with milk protein isolate (group B) and the third group will consume the foods with milk protein and 1,6 g arginine per day over a period of four weeks. After a wash-out period of six weeks, the diet will be crossed within the three groups for a second intervention period of four weeks. After another wash-out period, diet will be crossed within the three groups once again.
Arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the two groups receiving foods with milk protein. In the other groups (receiving foods with lupin protein or milk protein only) four placebo capsules will be served, containing mannitol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lupin protein | Experimental | Dietary Supplement: Fabricated foods with lupin protein, Dietary Supplement: MannitolLupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol |
| Milk protein | Active comparator | Dietary Supplement: Mannitol, Dietary Supplement: Fabricated foods with milk proteinMilk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules |
| Milk protein and arginine | Active comparator | Dietary Supplement: Arginine, Dietary Supplement: Fabricated foods with milk proteinMilk Protein Isoalte (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and 1,6 g Arginin in four caspules per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate Hypercholesterolemia (total cholesterol >= 5.2 mmol/L)
- Age: 20-80 years
Key exclusion criteria (5 listed)
- Intake of lipid-lowering pharmaceuticals
- Allergy against legumes
- Intolerance or allergy against milk
- Pregnancy, lactation
- Chronic bowel diseases
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 |
|---|---|---|
| Fabricated foods with lupin protein- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread) | Dietary supplement | Lupin protein |
| Mannitol- Placebo capsules containing mannitol (four capsules per day) | Dietary supplement | Lupin protein, Milk protein |
| Arginine- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g) | Dietary supplement | Milk protein and arginine |
| Fabricated foods with milk proteinFoods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread) | Dietary supplement | Milk protein, Milk protein and arginine |
Primary outcome
Changes in cholesterol metabolism
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
4 secondary outcomes
Changes in protein metabolism
Time frame: After 0,4, 10, 14, 20, and 24 weeks
Changes in body composition (body status)
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Changes in high-sensitive CRP
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Changes in parameter of diabetes mellitus
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
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 29 Oct 2013.
- Derived from this study: PubMed 24746974Bahr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fabricated foods with lupin protein, Mannitol and Arginine in people with Hypercholesterolemia, run by University of Jena 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 2 inclusion and 5 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 29 Oct 2013. 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. 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?
Changes in cholesterol metabolism (time frame: After 0, 4, 10, 14, 20, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598649, which also lists 1 linked publication.
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 29 Oct 2013.