Cholesterol-lowering Effects of Lupin Protein - Full Text View

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:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

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 May 16, 2013