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Cholesterol-lowering Effects of Lupin Protein

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Protein drink - low dosage
Protein drink - high dosage
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched drinks

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Friedrich Schiller University Jena, Department of Nutritional Physiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Lupin Protein

Reference protein

Wash out

Arm Description

Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)

Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)

Wash out (four weeks without any intervention between interventional periods)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Protein metabolism
Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study
Body composition (body status)
Bioelectrical impedance analysis, body weight, blood pressure
High-sensitive CRP
As inflammation marker
Fasting glucose

Full Information

First Posted
February 25, 2011
Last Updated
November 22, 2012
Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01304992
Brief Title
Cholesterol-lowering Effects of Lupin Protein
Official Title
Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Dietary protein, Lupin protein, Cholesterol metabolism, Protein metabolism, Hypercholesterolemia, Protein-enriched drinks

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lupin Protein
Arm Type
Experimental
Arm Description
Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)
Arm Title
Reference protein
Arm Type
Active Comparator
Arm Description
Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)
Arm Title
Wash out
Arm Type
No Intervention
Arm Description
Wash out (four weeks without any intervention between interventional periods)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein drink - low dosage
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein drink - high dosage
Intervention Description
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 Outcome Measure Information:
Title
Cholesterol metabolism
Description
Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)
Time Frame
After 0, 4, 8, 12, 16 and 20 weeks
Secondary Outcome Measure Information:
Title
Protein metabolism
Description
Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study
Time Frame
After 0, 8, 12 and 20 weeks
Title
Body composition (body status)
Description
Bioelectrical impedance analysis, body weight, blood pressure
Time Frame
After 0, 8, 12 and 20 weeks
Title
High-sensitive CRP
Description
As inflammation marker
Time Frame
After 0, 8, 12 and 20 weeks
Title
Fasting glucose
Time Frame
After 0, 8, 12 and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University Jena, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23902673
Citation
Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.
Results Reference
derived

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Cholesterol-lowering Effects of Lupin Protein

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