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

N/ACompletedNCT01320228

University of Copenhagen69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ratings of gastrointestinal comfort

Subjective assessment of gastrointestinal comfort using visual analogue scales

Time frame: baseline, week 0, 2, 4, 8, 12

Secondary Outcomes

Total fecal fat excretion

Average total fecal fat excreted during five days in week 0 and week 4

Time frame: week 0 and 4

Total, LDL and HDL cholesterol

Time frame: baseline and 12

Ratings of quality of life

Questionnaire used to assess quality of life related to obesity and treatment thereof

Time frame: baseline, week 0, 2, 4, 8 and 12

Body weight

Time frame: baseline, week 0, 2, 4, 6, 8, 10 and 12

Waist and hip circumference

Time frame: Baseline, week 0, 2, 4, 6, 8, 10 and 12

food intake

Intake of total fat and energi estimated using 7d weighed food records

Time frame: week 0 and 4

Habitual intake of dietary fiber and calcium

Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires

Time frame: baseline