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

Obesity Clinical Trial

— ORLIFAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320228
• Other study ID #: B274
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: September 1, 2014
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Control
Alli treatment plus placebo (rice flour)
• Capolac
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
• Flax fiber
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
• Capolac+Flax fiber
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	GlaxoSmithKline

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratings of gastrointestinal comfort	Subjective assessment of gastrointestinal comfort using visual analogue scales	baseline, week 0, 2, 4, 8, 12	No
Secondary	Total fecal fat excretion	Average total fecal fat excreted during five days in week 0 and week 4	week 0 and 4	No
Secondary	Total, LDL and HDL cholesterol		baseline and 12	No
Secondary	Ratings of quality of life	Questionnaire used to assess quality of life related to obesity and treatment thereof	baseline, week 0, 2, 4, 8 and 12	No
Secondary	Body weight		baseline, week 0, 2, 4, 6, 8, 10 and 12	No
Secondary	Waist and hip circumference		Baseline, week 0, 2, 4, 6, 8, 10 and 12	No
Secondary	food intake	Intake of total fat and energi estimated using 7d weighed food records	week 0 and 4	No
Secondary	Habitual intake of dietary fiber and calcium	Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires	baseline	No