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

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

Inclusion Criteria:

• 20-60 years of age
• men and women
• BMI 30-40 kg/m2

Exclusion Criteria:

• Dairy allergy and/or intolerance, allergy to Orlistat
• Infectious and metabolic diseases
• Gastrointestinal diseases (previous and current)
• Troubles swallowing tablets and capsules
• Dietary supplement use during the trial and 1 month prior to the trial
• Postmenopausal (selfreported)
• Pregnancy and lactation
• Treatment with oral anticoagulation medications, ciclosporin, levothyroxin, antiepileptika, acarbose and amiodaron
• Prescription medication will be considered on an individual basis at the screening visit according to SOP
• Dieting or other changes of diet within 3 months
• Participation in other trials