Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Fabricated foods with lupin protein; Dietary Supplement: Arginine; Dietary Supplement: Mannitol; Dietary Supplement: Fabricated foods with milk protein

• Registration Number: NCT01598649
• Lead Sponsor: University of Jena

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.

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 Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-15
• Study Start: 2012-06
• Primary Completion: 2012-12
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lupin protein	Fabricated foods with lupin protein	Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
Lupin protein	Mannitol	Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
Milk protein	Mannitol	Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules
Milk protein	Fabricated foods with 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
Milk protein and arginine	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
Milk protein and arginine	Fabricated foods with milk protein	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

Primary Outcome Measures

Name	Time	Method
Changes in cholesterol metabolism	After 0, 4, 10, 14, 20, and 24 weeks	Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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