NCT01320228

Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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 ®: 1. Alli® (60 mg t.i.d) plus placebo (rice flour) 2. Alli® plus 5 g flaxseed fibers 3. Alli® plus 1200 mg Ca from Capolac 4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Control	Alli treatment plus placebo (rice flour)
DIETARY_SUPPLEMENT	Capolac	Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
DIETARY_SUPPLEMENT	Flax fiber	Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
DIETARY_SUPPLEMENT	Capolac+Flax fiber	Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2011-03-22
• Last updated: 2014-09-03

Locations

1 site across 1 country: Denmark