Obesity
Conditions
Keywords
Obesity, orlistat, fat excretion, fiber, dairy calcium
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
Interventions
DIETARY_SUPPLEMENTControl
Alli treatment plus placebo (rice flour)
DIETARY_SUPPLEMENTCapolac
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
DIETARY_SUPPLEMENTFlax fiber
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
DIETARY_SUPPLEMENTCapolac+Flax fiber
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
Sponsors
GlaxoSmithKline
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratings of gastrointestinal comfort | baseline, week 0, 2, 4, 8, 12 | Subjective assessment of gastrointestinal comfort using visual analogue scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Total fecal fat excretion | week 0 and 4 | Average total fecal fat excreted during five days in week 0 and week 4 |
| 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 |
| Waist and hip circumference | Baseline, week 0, 2, 4, 6, 8, 10 and 12 | — |
Countries
Denmark
Outcome results
None listed