NCT01598649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

May 9, 2012

Last Update Submit

October 28, 2013

Conditions

Hypercholesterolemia

Keywords

Dietary proteinLupin proteinCholesterol metabolismProtein metabolismHypercholesterolemiaProtein-enriched foods

Outcome Measures

Primary Outcomes (1)

  • Changes in cholesterol metabolism

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

    After 0, 4, 10, 14, 20, and 24 weeks

Secondary Outcomes (4)

  • Changes in protein metabolism

    After 0,4, 10, 14, 20, and 24 weeks

  • Changes in body composition (body status)

    After 0, 4, 10, 14, 20, and 24 weeks

  • Changes in high-sensitive CRP

    After 0, 4, 10, 14, 20, and 24 weeks

  • Changes in parameter of diabetes mellitus

    After 0, 4, 10, 14, 20, and 24 weeks

Study Arms (3)

Lupin protein

EXPERIMENTAL

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

Dietary Supplement: Fabricated foods with lupin proteinDietary Supplement: Mannitol

Milk protein

ACTIVE COMPARATOR

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

Dietary Supplement: MannitolDietary Supplement: Fabricated foods with milk protein

Milk protein and arginine

ACTIVE COMPARATOR

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

Dietary Supplement: ArginineDietary Supplement: Fabricated foods with milk protein

Interventions

Fabricated foods with lupin proteinDIETARY_SUPPLEMENT

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

Lupin protein
MannitolDIETARY_SUPPLEMENT

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

Lupin proteinMilk protein
ArginineDIETARY_SUPPLEMENT

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

Milk protein and arginine
Fabricated foods with milk proteinDIETARY_SUPPLEMENT

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

Milk proteinMilk protein and arginine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate Hypercholesterolemia (total cholesterol \>= 5.2 mmol/L)
  • Age: 20-80 years

You may not qualify if:

  • Intake of lipid-lowering pharmaceuticals
  • Allergy against legumes
  • Intolerance or allergy against milk
  • Pregnancy, lactation
  • Chronic bowel diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24746974DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

MannitolArginineMilk Proteins

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialAnimal Proteins, DietaryDietary ProteinsProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and Beverages

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. habil.

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 15, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

October 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

DE(1)