NCT01304992

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

February 25, 2011

Last Update Submit

November 22, 2012

Conditions

Hypercholesterolemia

Keywords

Dietary proteinLupin proteinCholesterol metabolismProtein metabolismHypercholesterolemiaProtein-enriched drinks

Outcome Measures

Primary Outcomes (1)

  • Cholesterol metabolism

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

    After 0, 4, 8, 12, 16 and 20 weeks

Secondary Outcomes (4)

  • Protein metabolism

    After 0, 8, 12 and 20 weeks

  • Body composition (body status)

    After 0, 8, 12 and 20 weeks

  • High-sensitive CRP

    After 0, 8, 12 and 20 weeks

  • Fasting glucose

    After 0, 8, 12 and 20 weeks

Study Arms (3)

Lupin Protein

EXPERIMENTAL

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

Dietary Supplement: Protein drink - low dosageDietary Supplement: Protein drink - high dosage

Reference protein

ACTIVE COMPARATOR

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

Dietary Supplement: Protein drink - low dosageDietary Supplement: Protein drink - high dosage

Wash out

NO INTERVENTION

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

Interventions

Protein drink - low dosageDIETARY_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.

Lupin ProteinReference protein
Protein drink - high dosageDIETARY_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.

Lupin ProteinReference protein

Eligibility Criteria

Age18 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: 18-80 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23902673DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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

February 25, 2011

First Posted

February 28, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

DE(1)