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

University of Copenhagen

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Control; Dietary Supplement: Flax fiber; Dietary Supplement: Capolac+Flax fiber; Dietary Supplement: Capolac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01320228

B274

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Alli treatment plus placebo (rice flour)

Treatment:

Dietary Supplement: Control

Capolac

Experimental group

Description:

Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)

Treatment:

Dietary Supplement: Capolac

Flax fiber

Experimental group

Description:

Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)

Treatment:

Dietary Supplement: Flax fiber

Capolac+Flax fiber

Experimental group

Description:

Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Treatment:

Dietary Supplement: Capolac+Flax fiber