Supplementation with dairy calcium and/or flaxseed fibers in conjunction with orlistat augments fecal fat excretion without altering ratings of gastrointestinal comfort

Mette Kristensen, Signe Rømer Juul, Karina Vejrum Sørensen, Janne Kunchel Lorenzen, Arne Astrup, Mette Kristensen, Signe Rømer Juul, Karina Vejrum Sørensen, Janne Kunchel Lorenzen, Arne Astrup

Abstract

Background: Orlistat is a lipase inhibitor which reduced absorption of dietary fat by ~30% thereby inducing a weight loss; however, side effects occur as a consequence of increased colonic fat content. To test the hypothesis that most gastrointestinal side events induced by treatment with orlistat could be prevented/ameliorated by concomitant use of natural dietary components, flaxseed fiber (FF) and/or dairy calcium (Ca), binding liquid fats to more solid complexes.

Methods: A randomized controlled dietary intervention study. Thirty-eight obese adults completed a 1-week run-in period, where all participants were treated with orlistat (60 mg t.i.d) and were hereafter randomized to 12 weeks dietary supplementation with/without 5 g FF (FF+/FF-) and/or 1200 mg dairy calcium (Ca+/Ca-) in conjunction with orlistat. All feces were collected for 3 days, and diet was recorded for 5 days, during run-in and week 4. The primary end-point, gastrointestinal symptoms, was assessed biweekly. At baseline and after 12 weeks, cardiometabolic risk markers and anthropometrics were evaluated as secondary end-points.

Results: Both FF and Ca increased fecal fat excretion (P = 0.02 and P = 0.04, respectively). Although fecal fat excretion increased by ~100% in the FF+/Ca + group, and only by ~12% in the FF-/Ca + group, no interaction between FF and Ca was present, suggesting an additive effect. The fecal fat excretion was ~10 g/d higher with FF and Ca (~25 g/d) compared to fecal fat excretion with orlistat alone (~15 g/d). Mean ratings of severity of diarrhea tended to increase with Ca (P = 0.03) but not with FF. No other gastrointestinal symptoms, or a composite score of symptoms, were affected by the dietary supplements. Body weight was reduced in all groups but did not differ between groups, whereas waist circumference was most reduced in the FF+/Ca + group. No effects of dietary supplements on cardiometabolic risk factors were observed, except a slight increase in diastolic blood pressure (P = 0.03) with FF, but not Ca.

Conclusions: Our results do not support an improvement in orlistat-induced gastrointestinal side effects by concomitant use of FF and Ca. However, fecal fat excretion was increased with both FF and Ca in the absence of a worsening of symptoms, warranting further studies powered to detect potential additive weight loss effects.

Trial registration: Ethical Committee of the Capital Region of Denmark reg. no. H-1-2010-110, 02-11-2010 database no. NCT01320228, 21-03-2011.

Keywords: Calcium; Flaxseed; Obesity; Orlistat; Side effects; Weight loss.

Figures

Fig. 1
Fig. 1
Flow diagram: Parallel intervention study with orlistat treatment plus placebo supplement (FF-/Ca-) or flaxseed fibers (FF), and/or dairy Ca (Ca) supplements as part of an energy-restricted diet. The diagram includes detailed information about the study
Fig. 2
Fig. 2
Composite score for gastrointestinal symptoms. Mean frequency and severity of composite score of 9 gastrointestinal symptoms (oily stools; flatus; fecal urgency, fecal incontinence, flatus with oily discharge, loose stools, abdominal pain, diarrhea, frequent stools) during the 12 weeks intervention with orlistat plus placebo (FF-/Ca-) or flaxseed fibers (FF) and/or dairy Ca (Ca) supplements. The lower the score the less frequent or severe the symptom
Fig. 3
Fig. 3
Fecal fat excretion. Individual and mean change in fecal fat excretion (g/d) from baseline (orlistat treatment only) to week 4 (orlistat plus placebo (FF-/Ca-) or flaxseed fibers (FF) and/or dairy Ca (Ca) supplements). * Indicate a significant effect of Ca (p = 0.02) and # indicate a significant effect of FF (p = 0.04) compared to control in an ANCOVA

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