Clinical trial NCT01320228: Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Official title: Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
orlistat
fat excretion
fiber
dairy calcium
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-22
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 ®:

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


Eligibility 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

Primary outcomes:
measure: Ratings of gastrointestinal comfort
timeFrame: baseline, week 0, 2, 4, 8, 12
Secondary outcomes:
measure: Total fecal fat excretion
timeFrame: week 0 and 4
measure: Total, LDL and HDL cholesterol
timeFrame: baseline and 12
measure: Ratings of quality of life
timeFrame: baseline, week 0, 2, 4, 8 and 12
measure: Body weight
timeFrame: baseline, week 0, 2, 4, 6, 8, 10 and 12
measure: Waist and hip circumference
timeFrame: Baseline, week 0, 2, 4, 6, 8, 10 and 12
measure: food intake
timeFrame: week 0 and 4
measure: Habitual intake of dietary fiber and calcium
timeFrame: baseline
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
name: Arne Astrup, MD, Dr.med.
role: STUDY_DIRECTOR
References:
citation: Kristensen M, Juul SR, Sorensen KV, Lorenzen JK, Astrup A. Supplementation with dairy calcium and/or flaxseed fibers in conjunction with orlistat augments fecal fat excretion without altering ratings of gastrointestinal comfort. Nutr Metab (Lond). 2017 Feb 7;14:13. doi: 10.1186/s12986-017-0164-8. eCollection 2017.