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

NCT01320228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2014-09-03

No results posted yet for this study

Summary

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320228 on ClinicalTrials.gov