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Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01598649
Enrollment
72
Registered
2012-05-15
Start date
2012-06-30
Completion date
2013-10-31
Last updated
2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched foods

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.

Interventions

DIETARY_SUPPLEMENTFabricated foods with lupin protein

\- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)

DIETARY_SUPPLEMENTMannitol

\- Placebo capsules containing mannitol (four capsules per day)

DIETARY_SUPPLEMENTArginine

\- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)

DIETARY_SUPPLEMENTFabricated foods with milk protein

Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in cholesterol metabolismAfter 0, 4, 10, 14, 20, and 24 weeksBlood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)

Secondary

MeasureTime frameDescription
Changes in protein metabolismAfter 0,4, 10, 14, 20, and 24 weeksPlasma: amino acids, total protein, albumin, urea
Changes in body composition (body status)After 0, 4, 10, 14, 20, and 24 weeksBioelectrical impedance analysis, body weight, blood pressure
Changes in high-sensitive CRPAfter 0, 4, 10, 14, 20, and 24 weeksInflammation marker
Changes in parameter of diabetes mellitusAfter 0, 4, 10, 14, 20, and 24 weeksFasting glucose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026