Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 9, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date October 29, 2013
Study Start Date  ICMJE June 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
Official Title  ICMJE Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Bähr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
72
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
75
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598649
Other Study ID Numbers  ICMJE LSEP H52-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Jahreis, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
PRS Account University of Jena
Verification Date October 2013

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