HypercholesterolemiaNCT01304992
Cholesterol-lowering Effects of Lupin Protein
A study testing Protein drink - low dosage and Protein drink - high dosage in people with Hypercholesterolemia, run by University of Jena at 1 site in Germany.
Trial summary
The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Protein drink - low dosage and Protein drink - high dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Nov 2011
- 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 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: 18-80 years old
Who cannot join
- Intake of lipid-lowering pharmaceuticals
- Allergy against legumes or milk protein
- Intolerance against milk
- Pregnancy, lactation
- Chronic bowel disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, 07743
About this study
Official title: Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects
The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.
Read the detailed description
Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group A: 25 g protein/day; group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study conditions in a cross-over design.
In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Protein drink - low dosage, Protein drink - high dosage
- Keywords
- Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched drinks
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein drink - low dosageDietary supplement
The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Protein drink - high dosageDietary supplement
The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
| Study group | Role | What they receive |
|---|---|---|
| Lupin Protein | Experimental | Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink) Receives: Dietary Supplement: Protein drink - low dosage; Dietary Supplement: Protein drink - high dosage |
| Reference protein | Active comparator | Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink) Receives: Dietary Supplement: Protein drink - low dosage; Dietary Supplement: Protein drink - high dosage |
| Wash out | No intervention | Wash out (four weeks without any intervention between interventional periods) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol metabolism
Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)
Measured: After 0, 4, 8, 12, 16 and 20 weeks
Secondary outcomes (4)
Protein metabolism
Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study
Measured: After 0, 8, 12 and 20 weeks
Body composition (body status)
Bioelectrical impedance analysis, body weight, blood pressure
Measured: After 0, 8, 12 and 20 weeks
High-sensitive CRP
As inflammation marker
Measured: After 0, 8, 12 and 20 weeks
Fasting glucose
Measured: After 0, 8, 12 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionNov 2011
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
- 66 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
- NCT01304992
- Sponsor's protocol ID
- LSEP H48-11
- Status last verified
- Nov 2012
- First submitted
- 25 Feb 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
PubMed 23902673
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT01304992
- Acronym / sponsor ID
- LSEP H48-11
- Conditions
- Hypercholesterolemia
- Keywords
- Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched drinks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Feb 2011 (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 determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.
Detailed description
Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group A: 25 g protein/day; group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study conditions in a cross-over design.
In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.
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: Protein drink - low dosage, Dietary Supplement: Protein drink - high dosageLupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink) |
| Reference protein | Active comparator | Dietary Supplement: Protein drink - low dosage, Dietary Supplement: Protein drink - high dosageReference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink) |
| Wash out | No intervention | –Wash out (four weeks without any intervention between interventional periods) |
Who may qualify
- Ages
- 18 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: 18-80 years old
Key exclusion criteria (5 listed)
- Intake of lipid-lowering pharmaceuticals
- Allergy against legumes or milk protein
- Intolerance against milk
- Pregnancy, lactation
- Chronic bowel disease
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 |
|---|---|---|
| Protein drink - low dosageThe subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between. | Dietary supplement | Lupin Protein, Reference protein |
| Protein drink - high dosageThe subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between. | Dietary supplement | Lupin Protein, Reference protein |
Primary outcome
Cholesterol metabolism
Time frame: After 0, 4, 8, 12, 16 and 20 weeks
Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)
4 secondary outcomes
Protein metabolism
Time frame: After 0, 8, 12 and 20 weeks
Body composition (body status)
Time frame: After 0, 8, 12 and 20 weeks
High-sensitive CRP
Time frame: After 0, 8, 12 and 20 weeks
Fasting glucose
Time frame: After 0, 8, 12 and 20 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 27 Nov 2012.
- Derived from this study: PubMed 23902673Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
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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.
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 Protein drink - low dosage and Protein drink - high dosage 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 27 Nov 2012. 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?
Cholesterol metabolism (time frame: After 0, 4, 8, 12, 16 and 20 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 NCT01304992, 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 27 Nov 2012.