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

Prader-Willi syndrome (PWS) PWS is caused by three types of abnormality in chromosome 15 at a prevalence rate of 1:11,000 to 1:22,000. The defining feature of PWS is food-seeking behaviour due to constant hunger. Hyperphagia and obesity are one of the main burdens in PWS and obesity is linked to increased morbidity and mortality.

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

Exclusion Criteria27

Those without a confirmed diagnosis of PWS.
Those with PWS who do not speak English.
Those with PWS and any of the conditions listed below:
Impaired Glucose Tolerance IGT. Those people with PWS who have a prevalence of glucose intolerance or are considered to have an impaired glucose metabolism.
Type 1 diabetes
Type 2 diabetes.
Chronic Asthma
Metabolic syndrome
Past indications of kidney dysfunction
Liver damage
Heart disease
Bariatric surgery.
Severe sleep-apnea.
Those using night respiratory aids for sleeping.
Those in psychiatric care.
Those with a recorded history related to their inability to vomit.
Those with a recorded history of reduced pain sensitivity.
Those people with PWS who are not under supervision.
Excluded medications
Seizure medications. IE: phenabarbitone.
Medications for ADHD. IE: Retelin.
Psychiatric condition medications such as Antidepressants IE: Trycyclics.
Testosterone
Oestrogen
(Note: Because of puberty related issues with PWS drugs such as testosterone or oestrogen may have been implemented. These may confound the results.)
Carer exclusions
Carer who do not speak English

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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.

Locations(1)

New Zealand

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ACTRN12611000334909