Cholesterol-lowering Effects of Lupin Protein

University of Jena

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Protein drink - high dosage; Dietary Supplement: Protein drink - low dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT01304992

LSEP H48-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups

Lupin Protein

Experimental group

Description:

Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)

Treatment:

Dietary Supplement: Protein drink - low dosage

Dietary Supplement: Protein drink - high dosage

Reference protein

Active Comparator group

Description:

Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)

Treatment:

Dietary Supplement: Protein drink - low dosage

Dietary Supplement: Protein drink - high dosage

Wash out

No Intervention group

Description:

Wash out (four weeks without any intervention between interventional periods)