Cholesterol-lowering Effects of Lupin Protein

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:
NCT01304992
First received: February 25, 2011
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: Protein drink - low dosage
Dietary Supplement: Protein drink - high dosage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Cholesterol metabolism [ Time Frame: After 0, 4, 8, 12, 16 and 20 weeks ] [ Designated as safety issue: Yes ]
    Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)


Secondary Outcome Measures:
  • Protein metabolism [ Time Frame: After 0, 8, 12 and 20 weeks ] [ Designated as safety issue: Yes ]
    Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study

  • Body composition (body status) [ Time Frame: After 0, 8, 12 and 20 weeks ] [ Designated as safety issue: Yes ]
    Bioelectrical impedance analysis, body weight, blood pressure

  • High-sensitive CRP [ Time Frame: After 0, 8, 12 and 20 weeks ] [ Designated as safety issue: Yes ]
    As inflammation marker

  • Fasting glucose [ Time Frame: After 0, 8, 12 and 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lupin Protein
Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)
Dietary Supplement: Protein drink - low dosage
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.
Dietary Supplement: Protein drink - high dosage
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.
Active Comparator: Reference protein
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
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.
Dietary Supplement: Protein drink - high dosage
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.
No Intervention: Wash out
Wash out (four weeks without any intervention between interventional periods)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304992

Locations
Germany
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier: NCT01304992     History of Changes
Other Study ID Numbers: LSEP H48-11
Study First Received: February 25, 2011
Last Updated: November 22, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
Dietary protein
Lupin protein
Cholesterol metabolism
Protein metabolism
Hypercholesterolemia
Protein-enriched drinks

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014