Cholesterol-lowering Effects of Lupin Protein

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Protein drink - low dosage
* Dietary Supplement: Protein drink - high dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate hypercholesterolemia (total cholesterol >5,2 mmol/L) Age: 18-80 years old Exclusion Criteria: Intake of lipid-lowering pharmaceuticals Allergy against legumes or milk protein Intolerance against milk Pregnancy, lactation Chronic bowel disease

Ages Eligible for Study
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Minimum Age: 18 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 (cultivar: Lupinus angustifolius Boregine; incorporated in a drink) | Dietary Supplement: Protein drink - low dosage<br>* 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.<br>Dietary Supplement: Protein drink - high dosage<br>* 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.<br>|
| Active Comparator: Reference protein<br>Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink) | Dietary Supplement: Protein drink - low dosage<br>* 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.<br>Dietary Supplement: Protein drink - high dosage<br>* 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.<br>|
| No Intervention: Wash out<br>Wash out (four weeks without any intervention between interventional periods) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol metabolism | Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles) | After 0, 4, 8, 12, 16 and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 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 drinks