NCT01036308

Brief Summary

The objective of the conducted study was to determine the efficacy of the native legume kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop) and Glycine max Hefeng (Soy fibre) 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
76

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
Last Updated

November 6, 2012

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

December 17, 2009

Last Update Submit

November 5, 2012

Conditions

Healthy

Keywords

dietary fibrelegumeslupin kernel fibresoy fibrebile acidsshort-chain fatty acidscholesterol metabolismSubjects

Outcome Measures

Primary Outcomes (1)

  • Changes of serum lipids (cholesterol metabolism)

    after 2, 4 and 8 weeks

Secondary Outcomes (1)

  • Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion

    after 2, 4 and 8 weeks

Study Arms (3)

TypTop

EXPERIMENTAL

Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)

Dietary Supplement: pure fibre-productDietary Supplement: reference fibre

Soy fibre

EXPERIMENTAL

Glycine max Hefeng (soy fibre; dietary fibre content: 77%)

Dietary Supplement: pure fibre-productDietary Supplement: reference fibre

Boregine

EXPERIMENTAL

Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)

Dietary Supplement: pure fibre-productDietary Supplement: reference fibre

Interventions

pure fibre-productDIETARY_SUPPLEMENT

The subjects consumed 25 g pure fibre-product per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.

BoregineSoy fibreTypTop
reference fibreDIETARY_SUPPLEMENT

The subjects consumed 25 g reference fibre (citrus fibre: Herbacel AQ Plus; Herbafood Ingredients) per day over two weeks. One half a portion of the fibres was stirred into a selected milk product and the other half in juice.

Also known as: Herbacel AQ Plus, citrus fibre
BoregineSoy fibreTypTop

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-45 years
  • healthy subjects

You may not qualify if:

  • intake of pharmaceuticals and nutritional supplements
  • allergy against legumes
  • intolerance against milk protein
  • pregnancy, lactation
  • chronic 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, Fenske K, Jahreis G. Effects of legume kernel fibres and citrus fibre on putative risk factors for colorectal cancer: a randomised, double-blind, crossover human intervention trial. Nutr J. 2013 Jul 16;12:101. doi: 10.1186/1475-2891-12-101.

    PMID: 24060277DERIVED

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

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 21, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 6, 2012

Record last verified: 2009-12

Locations

DE(1)