Cholesterol-lowering Effects of Lupin Protein

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Protein drink - low dosage; Dietary Supplement: Protein drink - high dosage

• Registration Number: NCT01304992
• Lead Sponsor: University of Jena

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-22
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lupin Protein	Protein drink - low dosage	Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)
Lupin Protein	Protein drink - high dosage	Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)
Reference protein	Protein drink - low dosage	Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)
Reference protein	Protein drink - high dosage	Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)

Primary Outcome Measures

Name	Time	Method
Cholesterol metabolism	After 0, 4, 8, 12, 16 and 20 weeks	Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)

Secondary Outcome Measures

Name	Time	Method
Protein metabolism	After 0, 8, 12 and 20 weeks	Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study
Body composition (body status)	After 0, 8, 12 and 20 weeks	Bioelectrical impedance analysis, body weight, blood pressure
High-sensitive CRP	After 0, 8, 12 and 20 weeks	As inflammation marker
Fasting glucose	After 0, 8, 12 and 20 weeks

Trial Locations

Locations (1)

Friedrich Schiller University Jena, Department of Nutritional Physiology; 🇩🇪 Jena, Thuringia, Germany