A study on the satiety effect of Caralluma fimbriata extract for people with Prader - Willi syndrome (PWS).”
A study on children and adolescents with Prader-Willi syndrome, of Caralluma fimbriata extract and the placebo of maltodextrin/cabbage leaf, to determine any change in satiation on the markers of hyperphagia.
Victoria University
16 participants
Jun 24, 2011
Interventional
Conditions
Summary
From one and a half years of age, (average 8yrs) most with PWS feel a chronic hunger without the capacity to feel satiated. Nutritional requirements must be established through minimal food intake and locked behavioural parameters. Independence is rare for people with PWS. It is hypothesised that ingestion of the cactus succulent Caralluma Fimbriata, may evidence apetite control on the satiety markers within this small cohort of 16 children/adolescents with PWS; utilizing a controlled, double- blind cross-over pilot study. This is the most sort after correction for those with PWS and their families.
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Interventions
We propose to observe the capacity for the cactus succulent, Caralluma fimbriata extract (CFE) to relieve the sensation of persistent hunger for a small cohort of 16 children and adolescents with PWS. There will be two groups within the cross-over design. These will be called group A & group B, each comprising of 8 participants. The effect of the intervention/placebo, will be determined through daily oral supplementation with no invasive measures, over a period of four weeks, a wash out period of two weeks will then take place, followed by the cross-over to the other intervention or placebo. Dosage of the CFE intervention will be delineated by using a dose of 1000mg per adult in 250mg capsules. Four 250mg capsules a day, daily for four weeks. Dosage will be estimated relative to each participant's weight, at 250mg per 10 kilogram of body weight. The recommended adult dose (1000mg/d) will not be exceeded. The estimated dose will be taken daily, for four weeks and will not increase during the trial period.
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ACTRN12611000334909