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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupin protein | Experimental | Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fabricated foods with lupin protein | Dietary Supplement | - Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cholesterol metabolism | Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles) | After 0, 4, 10, 14, 20, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in protein metabolism | Plasma: amino acids, total protein, albumin, urea | After 0,4, 10, 14, 20, and 24 weeks |
| Changes in body composition (body status) | Bioelectrical impedance analysis, body weight, blood pressure |
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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 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24746974 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D001120 | Arginine |
| D008894 | Milk Proteins |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Mannitol | Dietary Supplement | - Placebo capsules containing mannitol (four capsules per day) |
|
| Arginine | Dietary Supplement | - Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g) |
|
| Fabricated foods with milk protein | Dietary Supplement | Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread) |
|
| After 0, 4, 10, 14, 20, and 24 weeks |
| Changes in high-sensitive CRP | Inflammation marker | After 0, 4, 10, 14, 20, and 24 weeks |
| Changes in parameter of diabetes mellitus | Fasting glucose | After 0, 4, 10, 14, 20, and 24 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D024361 |
| Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D008892 | Milk |
| D003611 | Dairy Products |
| D019602 | Food and Beverages |