Hypercholesterolemia
Conditions
Keywords
Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched drinks
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.
Interventions
DIETARY_SUPPLEMENTProtein drink - low dosage
The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
DIETARY_SUPPLEMENTProtein drink - high dosage
The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Sponsors
German Federal Ministry of Education and Research
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol metabolism | After 0, 4, 8, 12, 16 and 20 weeks | Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-sensitive CRP | After 0, 8, 12 and 20 weeks | As inflammation marker |
| Fasting glucose | After 0, 8, 12 and 20 weeks | — |
| Protein metabolism | After 0, 8, 12 and 20 weeks | Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study |
| Body composition (body status) | After 0, 8, 12 and 20 weeks | Bioelectrical impedance analysis, body weight, blood pressure |
Countries
Germany
Outcome results
None listed