HealthyNCT01036308
Intervention With Legume Kernel Fibre in Healthy Subjects
A study testing pure fibre-product and reference fibre in people with Healthy, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pure fibre-product and reference fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-45 years
- healthy subjects
Who cannot join
- intake of pharmaceuticals and nutritional supplements
- allergy against legumes
- intolerance against milk protein
- pregnancy, lactation
- chronic diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Jena, Thuringia, D-07743
About this study
Official title: Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- pure fibre-product, reference fibre
- Keywords
- dietary fibre, legumes, lupin kernel fibre, soy fibre, bile acids, short-chain fatty acids, cholesterol metabolism, Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
reference fibreDietary supplement
Also called Herbacel AQ Plus, citrus 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.
| Study group | Role | What they receive |
|---|---|---|
| TypTop | Experimental | Lupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%) Receives: Dietary Supplement: pure fibre-product; Dietary Supplement: reference fibre |
| Soy fibre | Experimental | Glycine max Hefeng (soy fibre; dietary fibre content: 77%) Receives: Dietary Supplement: pure fibre-product; Dietary Supplement: reference fibre |
| Boregine | Experimental | Lupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%) Receives: Dietary Supplement: pure fibre-product; Dietary Supplement: reference fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of serum lipids (cholesterol metabolism)
Measured: after 2, 4 and 8 weeks
Secondary outcomes (1)
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion
Measured: after 2, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036308
- Sponsor's protocol ID
- LSEP H32-07
- Status last verified
- Dec 2009
- First submitted
- 17 Dec 2009
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24060277
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Three Native Legume Kernel Fibres on Cholesterol Metabolism in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01036308
- Acronym / sponsor ID
- LSEP H32-07
- Conditions
- Healthy
- Keywords
- dietary fibre, legumes, lupin kernel fibre, soy fibre, bile acids, short-chain fatty acids, cholesterol metabolism, Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TypTop | Experimental | Dietary Supplement: pure fibre-product, Dietary Supplement: reference fibreLupinus albus Typ Top (lupin kernel fibre, dietary fibre content: 83%) |
| Soy fibre | Experimental | Dietary Supplement: pure fibre-product, Dietary Supplement: reference fibreGlycine max Hefeng (soy fibre; dietary fibre content: 77%) |
| Boregine | Experimental | Dietary Supplement: pure fibre-product, Dietary Supplement: reference fibreLupinus angustifolius Boregine (lupin kernel fibre, dietary fibre content: 87%) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 20-45 years
- healthy subjects
Key exclusion criteria (5 listed)
- intake of pharmaceuticals and nutritional supplements
- allergy against legumes
- intolerance against milk protein
- pregnancy, lactation
- chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pure fibre-productThe 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 | Boregine, Soy fibre, TypTop |
| reference fibreAlso: Herbacel AQ Plus, citrus fibreThe 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. | Dietary supplement | Boregine, Soy fibre, TypTop |
Primary outcome
Changes of serum lipids (cholesterol metabolism)
Time frame: after 2, 4 and 8 weeks
1 secondary outcome
Changes of general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion
Time frame: after 2, 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Derived from this study: PubMed 24060277Fechner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pure fibre-product and reference fibre in people with Healthy, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of serum lipids (cholesterol metabolism) (time frame: after 2, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012; AzTrials last refreshed its copy on 6 Nov 2026.