Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 11/30/2012 |
| Prvo podneseno: | 12/16/2009 |
| Predviđena prijava predata: | 12/16/2009 |
| Prvo objavljeno: | 12/17/2009 |
| Zadnje ažuriranje poslato: | 12/03/2012 |
| Posljednje ažuriranje objavljeno: | 12/04/2012 |
| Stvarni datum početka studija: | 05/31/2008 |
| Procijenjeni datum primarnog završetka: | 11/30/2008 |
| Predviđeni datum završetka studije: | 11/30/2008 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: fabricated food
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: Boregine Intervention: Lupinus angustifolius Boregine; 25 g lupin kernel fibre per day over 4 weeks; lupin kernel fibre was incorporated in different food | |
| 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 | |
| Placebo Comparator: Placebo different food without added fibre |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 20 Years To 20 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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 |
Ishod
Primarne mjere ishoda
1. cholesterol metabolism (blood lipids) [after 1, 5, 10 and 15 weeks]
Sekundarne mjere ishoda
1. general excretion parameters, neutral sterols, bile acids, short-chain fatty acids, fibre excretion, cytotoxicity, genotoxicity [after 1, 5, 10 and 15 weeks]
