Clinical trial NCT01304992: Cholesterol-lowering Effects of Lupin Protein
Official title: Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Dietary protein
Lupin protein
Cholesterol metabolism
Protein metabolism
Hypercholesterolemia
Protein-enriched drinks
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-02-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Cholesterol metabolism
timeFrame: After 0, 4, 8, 12, 16 and 20 weeks
Secondary outcomes:
measure: Protein metabolism
timeFrame: After 0, 8, 12 and 20 weeks
measure: Body composition (body status)
timeFrame: After 0, 8, 12 and 20 weeks
measure: High-sensitive CRP
timeFrame: After 0, 8, 12 and 20 weeks
measure: Fasting glucose
timeFrame: After 0, 8, 12 and 20 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.