Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
fabricated food
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesterolemia focused on measuring dietary fibre, lupin kernel fibre, bile acids, cholesterol metabolism, blood lipids, hypercholesterolemia, fibre-enriched food, moderate hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- moderate Hypercholesterolemia (total cholesterol > 5.2 mmol/L)
- age 20-75 years
Exclusion Criteria:
- intake of lipid-lowering pharmaceuticals
- intake of nutritional supplements
- allergy against legumes
- intolerance against milk protein
- pregnancy, lactation
- chronic bowel diseases
Sites / Locations
- Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Boregine
Reference
Placebo
Arm Description
Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
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
different food without added fibre
Outcomes
Primary Outcome Measures
cholesterol metabolism (blood lipids)
Secondary Outcome Measures
general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity
Full Information
NCT ID
NCT01035086
First Posted
December 17, 2009
Last Updated
December 4, 2012
Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01035086
Brief Title
Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
Official Title
The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 blood cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of lupin kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
dietary fibre, lupin kernel fibre, bile acids, cholesterol metabolism, blood lipids, hypercholesterolemia, fibre-enriched food, moderate hypercholesterolemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Boregine
Arm Type
Experimental
Arm Description
Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
different food without added fibre
Intervention Type
Dietary Supplement
Intervention Name(s)
fabricated food
Other Intervention Name(s)
diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
cholesterol metabolism (blood lipids)
Time Frame
after 1, 5, 10 and 15 weeks
Secondary Outcome Measure Information:
Title
general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity
Time Frame
after 1, 5, 10 and 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
moderate Hypercholesterolemia (total cholesterol > 5.2 mmol/L)
age 20-75 years
Exclusion Criteria:
intake of lipid-lowering pharmaceuticals
intake of nutritional supplements
allergy against legumes
intolerance against milk protein
pregnancy, lactation
chronic bowel diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
D-07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24572041
Citation
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.
Results Reference
derived
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Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
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