Intervention With Legume Kernel Fibre in Healthy Subjects

• Sponsor: University of Jena (Other)
• Overall Status: Completed
• CT.gov ID: NCT01036308
• Collaborator: German Federal Ministry of Education and Research (Other)
• Enrollment: 76
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 15.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: pure fibre-product; Dietary Supplement: reference fibre	N/A

Detailed Description

Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by binding the bile acids and by increasing the faecal mass. Bile acids, especially the secondary bile acids, are potential risk factors for colorectal cancer. A high bile acid-binding ability of fibre could lead to lower serum cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of legume kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

Seventy-eight healthy volunteers were enrolled. Seventy-six subjects (mean age of 24 years, 55 women and 21 men) completed the double-blind, randomized crossover trial. After two weeks run-in period, half of the volunteers consumed 25 g of legume fibres (Boregine, TypTop or Soy fibre) every day, and the other half received a reference fibre product (citrus fibre, Herbacel AQ Plus) for a period of two weeks. After two weeks wash-out the intervention changed between the groups.

At the end of each period a quantitative stool and urine collection took place and fasting blood samples were drawn.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TypTop Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%)	Dietary Supplement: pure fibre-product; 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.; Dietary Supplement: reference fibre; 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.; Other Names: Herbacel AQ Plus citrus fibre
Experimental: Soy fibre Glycine max Hefeng (soy fibre; dietary fibre content: 77%)	Dietary Supplement: pure fibre-product; 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.; Dietary Supplement: reference fibre; 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.; Other Names: Herbacel AQ Plus citrus fibre
Experimental: Boregine Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%)	Dietary Supplement: pure fibre-product; 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.; Dietary Supplement: reference fibre; 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.; Other Names: Herbacel AQ Plus citrus fibre

Outcome Measures

Primary Outcome Measures

1. Changes of serum lipids (cholesterol metabolism) [after 2, 4 and 8 weeks]

Secondary Outcome Measures

1. Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion [after 2, 4 and 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age 20-45 years

• healthy subjects

Exclusion Criteria:

• intake of pharmaceuticals and nutritional supplements

• allergy against legumes

• intolerance against milk protein

• pregnancy, lactation

• chronic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology	Jena	Thuringia	Germany	D-07743

Sponsors and Collaborators

• University of Jena
• German Federal Ministry of Education and Research

Investigators

• Principal Investigator: Gerhard Jahreis, Prof. Dr., Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01036308
• Other Study ID Numbers: LSEP H32-07
• First Posted: Dec 21, 2009
• Last Update Posted: Nov 6, 2012
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: dietary fibre; legumes; lupin kernel fibre; soy fibre; bile acids; short-chain fatty acids; cholesterol metabolism; Subjects

Study Results

No Results Posted as of Nov 6, 2012