ObesityORLIFATNCT01320228
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
A study testing Capolac, Flax fiber and Capolac+Flax fiber in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Capolac, Flax fiber and Capolac+Flax fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-60 years of age
- men and women
- BMI 30-40 kg/m2
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, 1958
About this study
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
- Conditions
- Obesity
- Being tested
- Control, Capolac, Flax fiber, Capolac+Flax fiber
- Keywords
- Obesity, orlistat, fat excretion, fiber, dairy calcium
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Alli treatment plus placebo (rice flour)
CapolacDietary supplement
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
Flax fiberDietary supplement
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
Capolac+Flax fiberDietary supplement
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Alli treatment plus placebo (rice flour) Receives: Dietary Supplement: Control |
| Capolac | Experimental | Alli treatment plus Capolac supplement (1200 Ca/d from Capolac) Receives: Dietary Supplement: Capolac |
| Flax fiber | Experimental | Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) Receives: Dietary Supplement: Flax fiber |
| Capolac+Flax fiber | Experimental | Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) Receives: Dietary Supplement: Capolac+Flax fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of gastrointestinal comfort
Subjective assessment of gastrointestinal comfort using visual analogue scales
Measured: baseline, week 0, 2, 4, 8, 12
Secondary outcomes (7)
Total fecal fat excretion
Average total fecal fat excreted during five days in week 0 and week 4
Measured: week 0 and 4
Total, LDL and HDL cholesterol
Measured: baseline and 12
Ratings of quality of life
Questionnaire used to assess quality of life related to obesity and treatment thereof
Measured: baseline, week 0, 2, 4, 8 and 12
Body weight
Measured: baseline, week 0, 2, 4, 6, 8, 10 and 12
Waist and hip circumference
Measured: Baseline, week 0, 2, 4, 6, 8, 10 and 12
food intake
Intake of total fat and energi estimated using 7d weighed food records
Measured: week 0 and 4
Habitual intake of dietary fiber and calcium
Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, MD, Dr.med., Study director, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320228
- Sponsor's protocol ID
- B274
- Acronym
- ORLIFAT
- Status last verified
- Sep 2014
- First submitted
- 21 Mar 2011
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28191026
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
- ClinicalTrials.gov ID
- NCT01320228
- Acronym / sponsor ID
- ORLIFAT / B274
- Conditions
- Obesity
- Keywords
- Obesity, orlistat, fat excretion, fiber, dairy calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlAlli treatment plus placebo (rice flour) |
| Capolac | Experimental | Dietary Supplement: CapolacAlli treatment plus Capolac supplement (1200 Ca/d from Capolac) |
| Flax fiber | Experimental | Dietary Supplement: Flax fiberAlli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) |
| Capolac+Flax fiber | Experimental | Dietary Supplement: Capolac+Flax fiberAllit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-60 years of age
- men and women
- BMI 30-40 kg/m2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlli treatment plus placebo (rice flour) | Dietary supplement | Control |
| CapolacAlli treatment plus Capolac supplement (1200 Ca/d from Capolac) | Dietary supplement | Capolac |
| Flax fiberAlli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) | Dietary supplement | Flax fiber |
| Capolac+Flax fiberAllit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) | Dietary supplement | Capolac+Flax fiber |
Primary outcome
Ratings of gastrointestinal comfort
Time frame: baseline, week 0, 2, 4, 8, 12
Subjective assessment of gastrointestinal comfort using visual analogue scales
7 secondary outcomes
Total fecal fat excretion
Time frame: week 0 and 4
Total, LDL and HDL cholesterol
Time frame: baseline and 12
Ratings of quality of life
Time frame: baseline, week 0, 2, 4, 8 and 12
Body weight
Time frame: baseline, week 0, 2, 4, 6, 8, 10 and 12
Waist and hip circumference
Time frame: Baseline, week 0, 2, 4, 6, 8, 10 and 12
food intake
Time frame: week 0 and 4
Habitual intake of dietary fiber and calcium
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Derived from this study: PubMed 28191026Kristensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, MD, Dr.med. study director
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capolac, Flax fiber and Capolac+Flax fiber in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratings of gastrointestinal comfort (time frame: baseline, week 0, 2, 4, 8, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.