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Completed

NCT Number: NCT01320228

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

Alli treatment plus placebo (rice flour)

Capolac

Dietary Supplement

Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)

Flax fiber

Dietary Supplement

Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)

Capolac+Flax fiber

Dietary Supplement

Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Primary outcomes

  1. Ratings of gastrointestinal comfort

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

    Subjective assessment of gastrointestinal comfort using visual analogue scales

Secondary outcomes

  1. Total fecal fat excretion

    Time frame: week 0 and 4

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

  2. Total, LDL and HDL cholesterol

    Time frame: baseline and 12

  3. 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

  4. Body weight

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

  5. Waist and hip circumference

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

  6. food intake

    Time frame: week 0 and 4

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

  7. Habitual intake of dietary fiber and calcium

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • GlaxoSmithKline

Registry information

Acronym: ORLIFAT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 22, 2011
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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