Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
NCT ID: NCT01035086
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2008-06-30
2008-12-31
Brief Summary
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Detailed Description
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A total of 133 subjects were recruited for this study. Sixty moderate hypercholesterolemic volunteers (total cholesterol \> 5.2 mmol/L) fulfilled the selection criteria and were randomly assigned three groups. Forty-five subjects (mean age of 47 years, 34 women and 20 men) completed the double-blind, randomized crossover trial.
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 baseline, each volunteer had to pass all three periods in different order with a two-week wash-out period between each.
At the end of each intervention period, subjects consumed a standardized diet for three days. Furthermore, a quantitative stool collection took place and fasting blood samples were drawn.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Boregine
Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
fabricated food
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.
Reference
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
fabricated food
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.
Placebo
different food without added fibre
fabricated food
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.
Interventions
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fabricated food
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 20-75 years
Exclusion Criteria
* intake of nutritional supplements
* allergy against legumes
* intolerance against milk protein
* pregnancy, lactation
* chronic bowel diseases
20 Years
75 Years
ALL
Yes
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
University of Jena
OTHER
Responsible Party
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Gerhard Jahreis
Prof. Dr. G. Jahreis
Principal Investigators
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Gerhard Jahreis, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Locations
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Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Jena, Thuringia, Germany
Countries
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References
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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.
Other Identifiers
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LSEP H36-08
Identifier Type: -
Identifier Source: org_study_id