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Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fabricated foods with lupin protein
Mannitol
Arginine
Fabricated foods with milk protein
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 foods

Eligibility Criteria

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

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

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

Active Comparator

Arm Label

Lupin protein

Milk protein

Milk protein and arginine

Arm Description

Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol

Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules

Milk Protein Isoalte (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and 1,6 g Arginin in four caspules per day

Outcomes

Primary Outcome Measures

Changes in cholesterol metabolism
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)

Secondary Outcome Measures

Changes in protein metabolism
Plasma: amino acids, total protein, albumin, urea
Changes in body composition (body status)
Bioelectrical impedance analysis, body weight, blood pressure
Changes in high-sensitive CRP
Inflammation marker
Changes in parameter of diabetes mellitus
Fasting glucose

Full Information

First Posted
May 9, 2012
Last Updated
October 28, 2013
Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01598649
Brief Title
Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects
Official Title
Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2013 (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 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.

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 foods

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lupin protein
Arm Type
Experimental
Arm Description
Lupin protein isolate (cultivar: Lupinus angustifolius Boregine; incorporated in study products) and placebo capsules with mannitol
Arm Title
Milk protein
Arm Type
Active Comparator
Arm Description
Milk Protein Isolate (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and Placebo capsules
Arm Title
Milk protein and arginine
Arm Type
Active Comparator
Arm Description
Milk Protein Isoalte (75% sodium caseinate (EM7; DMV international) and 25% whey protein (Megglosat HP; Meggle), incorporated in study products) and 1,6 g Arginin in four caspules per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Fabricated foods with lupin protein
Intervention Description
- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)
Intervention Type
Dietary Supplement
Intervention Name(s)
Mannitol
Intervention Description
- Placebo capsules containing mannitol (four capsules per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine
Intervention Description
- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fabricated foods with milk protein
Intervention Description
Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
Primary Outcome Measure Information:
Title
Changes in cholesterol metabolism
Description
Blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, cholesterol, triacylglyceroles)
Time Frame
After 0, 4, 10, 14, 20, and 24 weeks
Secondary Outcome Measure Information:
Title
Changes in protein metabolism
Description
Plasma: amino acids, total protein, albumin, urea
Time Frame
After 0,4, 10, 14, 20, and 24 weeks
Title
Changes in body composition (body status)
Description
Bioelectrical impedance analysis, body weight, blood pressure
Time Frame
After 0, 4, 10, 14, 20, and 24 weeks
Title
Changes in high-sensitive CRP
Description
Inflammation marker
Time Frame
After 0, 4, 10, 14, 20, and 24 weeks
Title
Changes in parameter of diabetes mellitus
Description
Fasting glucose
Time Frame
After 0, 4, 10, 14, 20, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 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: 20-80 years Exclusion Criteria: Intake of lipid-lowering pharmaceuticals Allergy against legumes Intolerance or allergy against milk Pregnancy, lactation Chronic bowel diseases
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
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24746974
Citation
Bahr M, Fechner A, Kiehntopf M, Jahreis G. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):7-14. doi: 10.1016/j.clnu.2014.03.008. Epub 2014 Apr 1.
Results Reference
derived

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Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

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