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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

March 21, 2011
March 21, 2011
April 2011
March 2012   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Obesity
  • Dietary Supplement: Control
    Alli treatment plus placebo (rice flour)
  • Dietary Supplement: Capolac
    Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
  • Dietary Supplement: Flax fiber
    Alli treatment plus flaxseed fibers (5 g/d of dietary fibers 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)
  • Placebo Comparator: Control
    Alli treatment plus placebo (rice flour)
    Intervention: Dietary Supplement: Control
  • Experimental: Capolac
    Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
    Intervention: Dietary Supplement: Capolac
  • Experimental: Flax fiber
    Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
    Intervention: Dietary Supplement: Flax fiber
  • Experimental: Capolac+Flax fiber
    Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
    Intervention: Dietary Supplement: Capolac+Flax fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
72
December 2013
March 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
Yes
Contact: Mette Kristensen, PhD +45 3533 3536 mekr@life.ku.dk
Denmark
 
NCT01320228
B274
No
Professor Arne Astrup, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
University of Copenhagen
GlaxoSmithKline
Study Director: Arne Astrup, MD, Dr.med. Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
University of Copenhagen
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP