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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupin Protein | Experimental | Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink) |
|
| Reference protein | Active Comparator | Reference 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein drink - low dosage | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol metabolism | Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles) | After 0, 4, 8, 12, 16 and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Protein metabolism | Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study | After 0, 8, 12 and 20 weeks |
| Body composition (body status) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Jahreis, Prof. Dr. | Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich Schiller University Jena, Department of Nutritional Physiology | Jena | Thuringia | 07743 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23902673 | Derived | 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. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| Protein drink - high dosage | Dietary 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. |
|
Bioelectrical impedance analysis, body weight, blood pressure
| After 0, 8, 12 and 20 weeks |
| High-sensitive CRP | As inflammation marker | After 0, 8, 12 and 20 weeks |
| Fasting glucose | After 0, 8, 12 and 20 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |