Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

Hypercholesterolemia Clinical Trial

Official title:

Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598649
• Other study ID #: LSEP H52-12
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: October 28, 2013
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

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:
• Fabricated foods with lupin protein
- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)
• Mannitol
- Placebo capsules containing mannitol (four capsules per day)
• Arginine
- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)
• Fabricated foods with milk protein
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)

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	Changes in cholesterol metabolism	Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)	After 0, 4, 10, 14, 20, and 24 weeks	Yes
Secondary	Changes in protein metabolism	Plasma: amino acids, total protein, albumin, urea	After 0,4, 10, 14, 20, and 24 weeks	Yes
Secondary	Changes in body composition (body status)	Bioelectrical impedance analysis, body weight, blood pressure	After 0, 4, 10, 14, 20, and 24 weeks	Yes
Secondary	Changes in high-sensitive CRP	Inflammation marker	After 0, 4, 10, 14, 20, and 24 weeks	Yes
Secondary	Changes in parameter of diabetes mellitus	Fasting glucose	After 0, 4, 10, 14, 20, and 24 weeks	Yes