Hypercholesterolemia
Conditions
Keywords
Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched foods
Brief 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.
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.
Interventions
\- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)
\- Placebo capsules containing mannitol (four capsules per day)
\- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
Sponsors
Study design
Eligibility
Inclusion criteria
* Moderate Hypercholesterolemia (total cholesterol \>= 5.2 mmol/L) * Age: 20-80 years
Exclusion criteria
* Intake of lipid-lowering pharmaceuticals * Allergy against legumes * Intolerance or allergy against milk * Pregnancy, lactation * Chronic bowel diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cholesterol metabolism | After 0, 4, 10, 14, 20, and 24 weeks | Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in protein metabolism | After 0,4, 10, 14, 20, and 24 weeks | Plasma: amino acids, total protein, albumin, urea |
| Changes in body composition (body status) | After 0, 4, 10, 14, 20, and 24 weeks | Bioelectrical impedance analysis, body weight, blood pressure |
| Changes in high-sensitive CRP | After 0, 4, 10, 14, 20, and 24 weeks | Inflammation marker |
| Changes in parameter of diabetes mellitus | After 0, 4, 10, 14, 20, and 24 weeks | Fasting glucose |
Countries
Germany