Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
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ClinicalTrials.gov Identifier: NCT01598649 |
Recruitment Status :
Completed
First Posted : May 15, 2012
Last Update Posted : October 29, 2013
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Condition or disease | Intervention/treatment | Phase |
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Hypercholesterolemia | Dietary Supplement: Fabricated foods with lupin protein Dietary Supplement: Mannitol Dietary Supplement: Arginine Dietary Supplement: Fabricated foods with milk protein | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | October 2013 |
Arm | Intervention/treatment |
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Experimental: Lupin protein
Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
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Dietary Supplement: Fabricated foods with lupin protein
- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread) Dietary Supplement: Mannitol - Placebo capsules containing mannitol (four capsules per day) |
Active Comparator: Milk protein
Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules
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Dietary Supplement: Mannitol
- Placebo capsules containing mannitol (four capsules per day) Dietary Supplement: Fabricated foods with milk protein Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread) |
Active Comparator: Milk protein and arginine
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
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Dietary Supplement: Arginine
- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g) Dietary Supplement: Fabricated foods with milk protein Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread) |
- Changes in cholesterol metabolism [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
- Changes in protein metabolism [ Time Frame: After 0,4, 10, 14, 20, and 24 weeks ]Plasma: amino acids, total protein, albumin, urea
- Changes in body composition (body status) [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]Bioelectrical impedance analysis, body weight, blood pressure
- Changes in high-sensitive CRP [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]Inflammation marker
- Changes in parameter of diabetes mellitus [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]Fasting glucose

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598649
Germany | |
Friedrich Schiller University Jena, Department of Nutritional Physiology | |
Jena, Thuringia, Germany |
Principal Investigator: | Gerhard Jahreis, Prof. Dr. | Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology |
Responsible Party: | Gerhard Jahreis, Prof. Dr. habil., University of Jena |
ClinicalTrials.gov Identifier: | NCT01598649 |
Other Study ID Numbers: |
LSEP H52-12 |
First Posted: | May 15, 2012 Key Record Dates |
Last Update Posted: | October 29, 2013 |
Last Verified: | October 2013 |
Dietary protein Lupin protein Cholesterol metabolism |
Protein metabolism Hypercholesterolemia Protein-enriched foods |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Mannitol Caseins |
Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |