Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

October 28, 2013 updated by: Gerhard Jahreis, University of Jena

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany
        • Friedrich Schiller University Jena, Department of Nutritional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Fabricated foods with milk protein
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
Dietary supplement: Arginine
- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 0, 4, 10, 14, 20, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in protein metabolism
Time Frame: After 0,4, 10, 14, 20, and 24 weeks
Plasma: amino acids, total protein, albumin, urea
After 0,4, 10, 14, 20, and 24 weeks
Changes in body composition (body status)
Time Frame: After 0, 4, 10, 14, 20, and 24 weeks
Bioelectrical impedance analysis, body weight, blood pressure
After 0, 4, 10, 14, 20, and 24 weeks
Changes in high-sensitive CRP
Time Frame: After 0, 4, 10, 14, 20, and 24 weeks
Inflammation marker
After 0, 4, 10, 14, 20, and 24 weeks
Changes in parameter of diabetes mellitus
Time Frame: After 0, 4, 10, 14, 20, and 24 weeks
Fasting glucose
After 0, 4, 10, 14, 20, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

German Federal Ministry of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP H52-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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