Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
NCT ID: NCT01320228 Phase: NA Status: COMPLETED Enrollment: 69 Completion: 2012-06
Conditions
Obesity
Interventions
Control, Capolac, Flax fiber, Capolac+Flax fiber
Summary
The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake, anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium concentrate (Capolac) in addition to treatment with Alli ®:
- Alli® (60 mg t.i.d) plus placebo (rice flour)
- Alli® plus 5 g flaxseed fibers
- Alli® plus 1200 mg Ca from Capolac
- Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac
Primary Outcome
Ratings of gastrointestinal comfort