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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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 ®:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Alli treatment plus placebo (rice flour) |
|
| Capolac | Experimental | Alli treatment plus Capolac supplement (1200 Ca/d from Capolac) |
|
| Flax fiber | Experimental | Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) |
|
| Capolac+Flax fiber | Experimental | Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | Alli treatment plus placebo (rice flour) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ratings of gastrointestinal comfort | Subjective assessment of gastrointestinal comfort using visual analogue scales | baseline, week 0, 2, 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Total fecal fat excretion | Average total fecal fat excreted during five days in week 0 and week 4 | week 0 and 4 |
| Total, LDL and HDL cholesterol | baseline and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, MD, Dr.med. | Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen | Frederiksberg C | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28191026 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Capolac |
| Dietary Supplement |
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac) |
|
| Flax fiber | Dietary Supplement | Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed) |
|
| Capolac+Flax fiber | Dietary Supplement | Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed) |
|
| 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 |
| 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 | Intake of total fat and energi estimated using 7d weighed food records | week 0 and 4 |
| Habitual intake of dietary fiber and calcium | Habitual intake of dietary fiber and calcium estimated using food frequency questionnaires | baseline |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |