Cholesterol-lowering Effects of Lupin Protein

Hypercholesterolemia Clinical Trial

Official title:

Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304992
• Other study ID #: LSEP H48-11
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: November 22, 2012
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Protein 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.
• Protein 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.

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterol metabolism	Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)	After 0, 4, 8, 12, 16 and 20 weeks	Yes
Secondary	Protein metabolism	Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study	After 0, 8, 12 and 20 weeks	Yes
Secondary	Body composition (body status)	Bioelectrical impedance analysis, body weight, blood pressure	After 0, 8, 12 and 20 weeks	Yes
Secondary	High-sensitive CRP	As inflammation marker	After 0, 8, 12 and 20 weeks	Yes
Secondary	Fasting glucose		After 0, 8, 12 and 20 weeks	Yes