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Fiber intervention for Prader-Willi Syndrome

N/A

Waitlist Available

Led By Andrea Haqq, MD, MHS

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, 3, 7 &10

Awards & highlights

Study Summary

This trial will study whether dietary fibers can help with hyperphagia (overeating) and other problems in children with Prader-Willi syndrome.

Eligible Conditions

Prader-Willi Syndrome
Binge Eating

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, 3, 7 &10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1, 3, 7 &10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, 3, 7 &10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in hyperphagia

Secondary outcome measures

Change in anthropometric measurements

Changes in appetite and satiety hormones

Changes in gut microbiota

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fiber interventionExperimental Treatment1 Intervention

The investigator's targeted supplemental fiber mixture (35 g total) will be composed of 6g of fiber from oligofructose + 10g from resistant maltodextrin + 12g from acacia gum + 4g from whole foods + 3g from RS2; and will be split into three meals each day.

Group II: Placebo treatmentPlacebo Group1 Intervention

Maltodextrin will be used as a placebo control, as it is digested in the small intestine and thus does not exert local effects in the colon.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,764 Total Patients Enrolled

Andrea Haqq, MD, MHSPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment offer the opportunity of involvement to individuals like myself?

"This research experiment is looking for approximately 20 patients that have Royer Syndrome as well as ages between 5 and 25 to qualify."

Answered by AI

To what extent is this research project being conducted with participants?

"Affirmative, clinicaltrials.gov informs potential participants that this trial is currently recruiting. It was initially posted on July 1st 2019 and the latest update was made in April 5th 2022. At present, 20 people are sought from two medical centres."

Answered by AI

Are there available slots in this experiment to enroll volunteers?

"That is correct. Evidenced by the information on clinicaltrials.gov, this medical study has been actively recruiting since July 1st 2019 and was most recently updated on April 5th 2022. The research team requires 20 participants from two distinct centres for their experiment."

Answered by AI

Recent research and studies

Advances in PediatricsJournal

Prader Willi Syndrome

Irizarry, Krystal A., Mark Miller, Michael Freemark, and Andrea M. Haqq. 2016. “Prader Willi Syndrome”. Advances in Pediatrics. Elsevier BV. doi:10.1016/j.yapd.2016.04.005.

EBioMedicineJournal

Dietary Modulation of Gut Microbiota Contributes to Alleviation of Both Genetic and Simple Obesity in Children

Zhang, Chenhong, Aihua Yin, Hongde Li, Ruirui Wang, Guojun Wu, Jian Shen, Menghui Zhang, et al.. 2015. “Dietary Modulation of Gut Microbiota Contributes to Alleviation of Both Genetic and Simple Obesity in Children”. Ebiomedicine. Elsevier BV. doi:10.1016/j.ebiom.2015.07.007.

Clinical EndocrinologyJournal

Metabolic Profiling in Prader-willi Syndrome and Nonsyndromic Obesity: Sex Differences and the Role of Growth Hormone

Irizarry, Krystal A., James Bain, Merlin G. Butler, Olga Ilkayeva, Michael Muehlbauer, Andrea M. Haqq, and Michael Freemark. 2015. “Metabolic Profiling in Prader-willi Syndrome and Nonsyndromic Obesity: Sex Differences and the Role of Growth Hormone”. Clinical Endocrinology. Wiley. doi:10.1111/cen.12766.

clinicaltrials.govStudy