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
  Purpose

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 Intervention
Hypercholesterolemia
Dietary Supplement: Fabricated foods with lupin protein
Dietary Supplement: Mannitol
Dietary Supplement: Arginine
Dietary Supplement: Fabricated foods with milk protein

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: Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 72
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598649

Locations
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
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: NCT01598649     History of Changes
Other Study ID Numbers: LSEP H52-12
Study First Received: May 9, 2012
Last Updated: October 28, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014