Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

University of Jena

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Fabricated foods with lupin protein; Dietary Supplement: Arginine; Dietary Supplement: Fabricated foods with milk protein; Dietary Supplement: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT01598649

LSEP H52-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups

Lupin protein

Experimental group

Description:

Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol

Treatment:

Dietary Supplement: Fabricated foods with lupin protein

Dietary Supplement: Mannitol

Milk protein

Active Comparator group

Description:

Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules

Treatment:

Dietary Supplement: Fabricated foods with milk protein

Dietary Supplement: Mannitol

Milk protein and arginine

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Fabricated foods with milk protein

Dietary Supplement: Arginine