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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
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Fabricated foods with lupin protein Dietary Supplement: Mannitol Dietary Supplement: Arginine Dietary Supplement: Fabricated foods with milk protein Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lupin protein
Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
 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
 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
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes in protein metabolism [ Time Frame: After 0,4, 10, 14, 20, and 24 weeks ]
    Plasma: amino acids, total protein, albumin, urea

  2. Changes in body composition (body status) [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]
    Bioelectrical impedance analysis, body weight, blood pressure

  3. Changes in high-sensitive CRP [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]
    Inflammation marker

  4. Changes in parameter of diabetes mellitus [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ]
    Fasting glucose


Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Gerhard Jahreis, University of Jena:
Dietary protein
Lupin protein
Cholesterol metabolism
 Protein metabolism
Hypercholesterolemia
Protein-enriched foods
Additional relevant MeSH terms:
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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