Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Fabricated foods with lupin protein
* Dietary Supplement: Mannitol
* Dietary Supplement: Arginine
* Dietary Supplement: Fabricated foods with milk protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lupin protein<br>Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol | Dietary Supplement: Fabricated foods with lupin protein<br>* - Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)<br>Dietary Supplement: Mannitol<br>* - Placebo capsules containing mannitol (four capsules per day)<br>|
| Active Comparator: Milk protein<br>Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules | Dietary Supplement: Mannitol<br>* - Placebo capsules containing mannitol (four capsules per day)<br>Dietary Supplement: Fabricated foods with milk protein<br>* Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)<br>|
| Active Comparator: Milk protein and arginine<br>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 | Dietary Supplement: Arginine<br>* - Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)<br>Dietary Supplement: Fabricated foods with milk protein<br>* Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched foods