Clinical trial NCT01598649: Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
Official title: Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Dietary protein
Lupin protein
Cholesterol metabolism
Protein metabolism
Hypercholesterolemia
Protein-enriched foods
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-05-15
Enrollment: 72
Sex: ALL
Minimum age (years): 20
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in cholesterol metabolism
timeFrame: After 0, 4, 10, 14, 20, and 24 weeks
Secondary outcomes:
measure: Changes in protein metabolism
timeFrame: After 0,4, 10, 14, 20, and 24 weeks
measure: Changes in body composition (body status)
timeFrame: After 0, 4, 10, 14, 20, and 24 weeks
measure: Changes in high-sensitive CRP
timeFrame: After 0, 4, 10, 14, 20, and 24 weeks
measure: Changes in parameter of diabetes mellitus
timeFrame: After 0, 4, 10, 14, 20, and 24 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, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.