Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Dietary Supplement: Fabricated foods with lupin protein Dietary Supplement: Mannitol Dietary Supplement: Arginine Dietary Supplement: Fabricated foods with milk protein	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
Study Start Date :	June 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know

Drug Information available for: Mannitol

U.S. FDA Resources

Arms and Interventions

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: 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)

Outcome Measures

Primary Outcome Measures :

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)

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier:	NCT01598649 History of Changes
Other Study ID Numbers:	LSEP H52-12
First Posted:	May 15, 2012 Key Record Dates
Last Update Posted:	October 29, 2013
Last Verified:	October 2013

Keywords provided by Gerhard Jahreis, 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

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