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

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT01320228

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 ®:

Alli® (60 mg t.i.d) plus placebo (rice flour)
Alli® plus 5 g flaxseed fibers
Alli® plus 1200 mg Ca from Capolac
Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Control Dietary Supplement: Capolac Dietary Supplement: Flax fiber Dietary Supplement: Capolac+Flax fiber	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Ratings of gastrointestinal comfort [baseline, week 0, 2, 4, 8, 12]
Subjective assessment of gastrointestinal comfort using visual analogue scales

Secondary Outcome Measures

Total fecal fat excretion [week 0 and 4]
Average total fecal fat excreted during five days in week 0 and week 4
Total, LDL and HDL cholesterol [baseline and 12]
Ratings of quality of life [baseline, week 0, 2, 4, 8 and 12]
Questionnaire used to assess quality of life related to obesity and treatment thereof
Body weight [baseline, week 0, 2, 4, 6, 8, 10 and 12]
Waist and hip circumference [Baseline, week 0, 2, 4, 6, 8, 10 and 12]
food intake [week 0 and 4]
Intake of total fat and energi estimated using 7d weighed food records
Habitual intake of dietary fiber and calcium [baseline]
Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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