Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia |
Dietary Supplement: fabricated food |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Preventive Effects of Lupin Kernel Fibre-enriched Food on Colon Cancer and Cardiovascular Diseases in Moderate Hypercholesterolemic Subjects |
- cholesterol metabolism (blood lipids) [ Time Frame: after 1, 5, 10 and 15 weeks ] [ Designated as safety issue: Yes ]
- general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity [ Time Frame: after 1, 5, 10 and 15 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 54 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Boregine
Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food
|
Dietary Supplement: 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 Name: diet
|
|
Active Comparator: 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
|
Dietary Supplement: 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 Name: diet
|
|
Placebo Comparator: Placebo
different food without added fibre
|
Dietary Supplement: 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 Name: diet
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Germany | |
| Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology | |
| Jena, Thuringia, Germany, D-07743 | |
| Principal Investigator: | Gerhard Jahreis, Prof. Dr. | Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology |
More Information
No publications provided
| Responsible Party: | Gerhard Jahreis, Prof. Dr. G. Jahreis, University of Jena |
| ClinicalTrials.gov Identifier: | NCT01035086 History of Changes |
| Other Study ID Numbers: | LSEP H36-08 |
| Study First Received: | December 17, 2009 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Jena:
|
dietary fibre lupin kernel fibre bile acids cholesterol metabolism |
blood lipids hypercholesterolemia fibre-enriched food moderate hypercholesterolemia |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypercholesterolemia Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013