NCT01035086

Brief Summary

The objective of the conducted study was to determine the efficacy of lupin kernel fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

December 17, 2009

Last Update Submit

December 4, 2012

Conditions

Hypercholesterolemia

Keywords

dietary fibrelupin kernel fibrebile acidscholesterol metabolismblood lipidshypercholesterolemiafibre-enriched foodmoderate hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • cholesterol metabolism (blood lipids)

    after 1, 5, 10 and 15 weeks

Secondary Outcomes (1)

  • general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity

    after 1, 5, 10 and 15 weeks

Study Arms (3)

Boregine

EXPERIMENTAL

Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food

Dietary Supplement: fabricated food

Reference

ACTIVE COMPARATOR

Intervention: Reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood ingredients); 25 g citrus fibre per day over 4 weeks; the citrus fibre was incorporated in different food

Dietary Supplement: fabricated food

Placebo

PLACEBO COMPARATOR

different food without added fibre

Dietary Supplement: fabricated food

Interventions

fabricated foodDIETARY_SUPPLEMENT

The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After a one-week run-in period, each volunteer had to pass all three periods (arms) in different order with a two-week wash-out period between each.

Also known as: diet
BoreginePlaceboReference

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate Hypercholesterolemia (total cholesterol \> 5.2 mmol/L)
  • age 20-75 years

You may not qualify if:

  • intake of lipid-lowering pharmaceuticals
  • intake of nutritional supplements
  • allergy against legumes
  • intolerance against milk protein
  • pregnancy, lactation
  • chronic bowel diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jena, Thuringia, D-07743, Germany

Location

Related Publications (1)

  • Fechner A, Kiehntopf M, Jahreis G. The formation of short-chain fatty acids is positively associated with the blood lipid-lowering effect of lupin kernel fiber in moderately hypercholesterolemic adults. J Nutr. 2014 May;144(5):599-607. doi: 10.3945/jn.113.186858. Epub 2014 Feb 26.

    PMID: 24572041DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Diet

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional 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. G. Jahreis

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

DE(1)