Childhood obesity treatment: double blinded trial on dietary fibres
(glucomannan) versus placebo.
Padiatr Padol. 1993;28(5):133-6.
Vido L, Facchin P, Antonello I, Gobber D, Rigon F.
Department of Pediatrics, University of Padova, Italy.
Dietary fibres are frequently used for the treatment of paediatric
obesity. The aim of this clinical trial is to evaluate the efficacy
of glucomannan in the child obesity management. This experimental design
was double blinded with a block randomisation, alpha = 0.05, beta =
0.2 and delta = 50%. The study involved 60 children under 15 years of
age (mean age 11.2 years, mean overweight 46%), 30 of them under glucomannan
treatment (1 g twice a day for two months) and 30 under placebo and
the same schedule. The drug and the placebo were indistinguishable both
for the family and the physician. During the two months study period
the children followed a normocaloric diet evaluated every two weeks
by a dietetic record book. At the beginning of the study the drug and
the placebo groups were comparable in regards to anthropometric data.
At the end, the mean overweight of the drug group was decreased from
49.5% to 41% and that of the placebo group from 43.9% to 41.7%. Both
decreases were significant (p < 0.01), but no significant difference
was observed between the drug and the placebo groups. The only significant
difference concerned the lipid metabolism. The children under glucomannan
treatment manifested a significant decrease of alpha-lipoprotein and
an increase of pre-beta-lipoprotein and triglycerides; the children
under placebo manifested only a decrease of triglycerides and apo beta-lipoprotein.
We suggest that this metabolic alteration may derive from a primary
decrease of alpha-lipoprotein, most likely because of an inadequate
water intake.(ABSTRACT TRUNCATED AT 250 WORDS)
Randomized Controlled Trial