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Completed

NCT Number: NCT01304992

Cholesterol-lowering Effects of Lupin Protein

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein drink - low dosage

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Cholesterol metabolism

    Time frame: After 0, 4, 8, 12, 16 and 20 weeks

    Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)

Secondary outcomes

  1. Protein metabolism

    Time frame: 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

  2. Body composition (body status)

    Time frame: After 0, 8, 12 and 20 weeks

    Bioelectrical impedance analysis, body weight, blood pressure

  3. High-sensitive CRP

    Time frame: After 0, 8, 12 and 20 weeks

    As inflammation marker

  4. Fasting glucose

    Time frame: After 0, 8, 12 and 20 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2011
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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