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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01320228
First received: March 21, 2011
Last updated: September 1, 2014
Last verified: September 2014
  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 ®:

  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

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:


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


Enrollment: 69
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, Denmark, 1958
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: Arne Astrup, Professer, Dr. Med., University of Copenhagen
ClinicalTrials.gov Identifier: NCT01320228     History of Changes
Other Study ID Numbers: B274
Study First Received: March 21, 2011
Last Updated: September 1, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
Obesity
orlistat
fat excretion
fiber
dairy calcium

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Orlistat
Anti-Obesity Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014