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

September 1, 2014 updated by: Arne Astrup, University of Copenhagen

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg C, Denmark, 1958
        • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Alli treatment plus placebo (rice flour)
Dietary supplement: Control
Alli treatment plus placebo (rice flour)
EXPERIMENTAL: Capolac
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
Dietary supplement: Capolac
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
EXPERIMENTAL: Flax fiber
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
Dietary supplement: Flax fiber
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
EXPERIMENTAL: Capolac+Flax fiber
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
Dietary supplement: Capolac+Flax fiber
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

GlaxoSmithKline

Investigators

  • Study Director: Arne Astrup, MD, Dr.med., Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (ESTIMATE)

March 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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