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Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01598649
First received: May 9, 2012
Last updated: October 28, 2013
Last verified: October 2013

May 9, 2012
October 28, 2013
June 2012
December 2012   (final data collection date for primary outcome measure)
Changes in cholesterol metabolism [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ] [ Designated as safety issue: Yes ]
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
Same as current
Complete list of historical versions of study NCT01598649 on ClinicalTrials.gov Archive Site
  • Changes in protein metabolism [ Time Frame: After 0,4, 10, 14, 20, and 24 weeks ] [ Designated as safety issue: Yes ]
    Plasma: amino acids, total protein, albumin, urea
  • Changes in body composition (body status) [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ] [ Designated as safety issue: Yes ]
    Bioelectrical impedance analysis, body weight, blood pressure
  • Changes in high-sensitive CRP [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ] [ Designated as safety issue: Yes ]
    Inflammation marker
  • Changes in parameter of diabetes mellitus [ Time Frame: After 0, 4, 10, 14, 20, and 24 weeks ] [ Designated as safety issue: Yes ]
    Fasting glucose
Same as current
Not Provided
Not Provided
 
Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypercholesterolemia
  • 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)
  • 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)
  • Experimental: Lupin protein
    Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
    Interventions:
    • Dietary Supplement: Fabricated foods with lupin protein
    • Dietary Supplement: Mannitol
  • 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
    Interventions:
    • Dietary Supplement: Mannitol
    • Dietary Supplement: Fabricated foods with milk protein
  • 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
    Interventions:
    • Dietary Supplement: Arginine
    • Dietary Supplement: Fabricated foods with milk protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01598649
LSEP H52-12
Yes
Gerhard Jahreis, University of Jena
University of Jena
German Federal Ministry of Education and Research
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
University of Jena
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP