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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Capolac; Dietary Supplement: Flax fiber; Dietary Supplement: Control; Dietary Supplement: Capolac+Flax fiber

• Registration Number: NCT01320228
• Lead Sponsor: University of Copenhagen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ratings of gastrointestinal comfort	baseline, week 0, 2, 4, 8, 12	Subjective assessment of gastrointestinal comfort using visual analogue scales

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen; 🇩🇰 Frederiksberg C, Denmark