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

Study Overview
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Brief Summary
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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

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Control
* Dietary Supplement: Capolac
* Dietary Supplement: Flax fiber
* Dietary Supplement: Capolac+Flax fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Alli treatment plus placebo (rice flour) | Dietary Supplement: Control<br>* Alli treatment plus placebo (rice flour)<br>|
| Experimental: Capolac<br>Alli treatment plus Capolac supplement (1200 Ca/d from Capolac) | Dietary Supplement: Capolac<br>* Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)<br>|
| Experimental: Flax fiber<br>Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) | Dietary Supplement: Flax fiber<br>* Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)<br>|
| Experimental: Capolac+Flax fiber<br>Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) | Dietary Supplement: Capolac+Flax fiber<br>* Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of gastrointestinal comfort | Subjective assessment of gastrointestinal comfort using visual analogue scales | baseline, week 0, 2, 4, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fecal fat excretion | Average total fecal fat excreted during five days in week 0 and week 4 | week 0 and 4 | 
| Total, LDL and HDL cholesterol |  | baseline and 12 | 
| Ratings of quality of life | Questionnaire used to assess quality of life related to obesity and treatment thereof | baseline, week 0, 2, 4, 8 and 12 | 
| Body weight |  | baseline, week 0, 2, 4, 6, 8, 10 and 12 | 
| Waist and hip circumference |  | Baseline, week 0, 2, 4, 6, 8, 10 and 12 | 
| food intake | Intake of total fat and energi estimated using 7d weighed food records | week 0 and 4 | 
| Habitual intake of dietary fiber and calcium | Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, orlistat, fat excretion, fiber, dairy calcium