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

This study is not yet open for participant recruitment.

Verified March 2011 by University of Copenhagen

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01320228

First received: March 21, 2011

Last updated: NA

Last verified: March 2011

History: No changes posted

Purpose

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

Condition	Intervention
Obesity	Dietary Supplement: Control Dietary Supplement: Capolac Dietary Supplement: Flax fiber Dietary Supplement: Capolac+Flax fiber

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Fiber Dietary Supplements Obesity

Drug Information available for: Orlistat

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

Ratings of gastrointestinal comfort [ Time Frame: baseline, week 0, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
Subjective assessment of gastrointestinal comfort using visual analogue scales

Secondary Outcome Measures:

Total fecal fat excretion [ Time Frame: week 0 and 4 ] [ Designated as safety issue: No ]
Average total fecal fat excreted during five days in week 0 and week 4
Total, LDL and HDL cholesterol [ Time Frame: baseline and 12 ] [ Designated as safety issue: No ]
Ratings of quality of life [ Time Frame: baseline, week 0, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Questionnaire used to assess quality of life related to obesity and treatment thereof
Body weight [ Time Frame: baseline, week 0, 2, 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
Waist and hip circumference [ Time Frame: Baseline, week 0, 2, 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
food intake [ Time Frame: week 0 and 4 ] [ Designated as safety issue: No ]
Intake of total fat and energi estimated using 7d weighed food records
Habitual intake of dietary fiber and calcium [ Time Frame: baseline ] [ Designated as safety issue: No ]
Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires

Estimated Enrollment:	72
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320228

Contacts

Contact: Mette Kristensen, PhD

+45 3533 3536

mekr@life.ku.dk

Locations

Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Not yet recruiting
Frederiksberg C, Denmark, 1958
Contact: Mette Kristensen, PhD +45 3533 3536 mekr@life.ku.dk
Principal Investigator: Mette Kristensen, PhD

Sponsors and Collaborators

University of Copenhagen

GlaxoSmithKline

Investigators

Study Director:

Arne Astrup, MD, Dr.med.

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

More Information

No publications provided

Responsible Party:	Professor Arne Astrup, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT01320228 History of Changes
Other Study ID Numbers:	B274
Study First Received:	March 21, 2011
Last Updated:	March 21, 2011
Health Authority:	Denmark: Ethics Committee

Keywords provided by University of Copenhagen:

Obesity
orlistat
fat excretion
fiber
dairy calcium

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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