RecruitingPhase 1ACTRN12611000334909

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.


Sponsor

Victoria University

Enrollment

16 participants

Start Date

Jun 24, 2011

Study Type

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.


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a natural supplement called Caralluma fimbriata (a type of cactus plant) can reduce hunger in children and teenagers with Prader-Willi syndrome (PWS). PWS is a genetic condition that causes a constant, severe feeling of hunger that is very difficult to control. This double-blind crossover study (where neither families nor researchers know who gets the real supplement versus a dummy pill) will test whether Caralluma fimbriata can safely reduce appetite signals in young people with PWS. You may be eligible if: - Your child is between 5 and 17 years old - Your child has a confirmed genetic diagnosis of Prader-Willi syndrome - Your child is in good general health with typical features of PWS - Your child is under constant adult supervision - English is spoken in the home You may NOT be eligible if: - Your child has diabetes (type 1 or 2) or glucose intolerance - Your child has chronic asthma, heart disease, liver or kidney problems, or severe sleep apnoea - Your child is on seizure medications, ADHD medications, antidepressants, or testosterone/oestrogen - Your child is in psychiatric care Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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.


Locations(1)

New Zealand

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ACTRN12611000334909