Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany
NCT Number: NCT01598649
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.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Jena, Thuringia, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
Time frame: After 0,4, 10, 14, 20, and 24 weeks
Plasma: amino acids, total protein, albumin, urea
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Bioelectrical impedance analysis, body weight, blood pressure
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Inflammation marker
Time frame: After 0, 4, 10, 14, 20, and 24 weeks
Fasting glucose
University of Jena
Other
Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
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