- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629119
PsylliumRx Dietary Fiber Study
PsylliumRx: Use of Dietary Fiber in Severely Obese Children to Delay the Onset of Obesity-related Health Conditions - Pilot
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For this 3-month clinical pilot trial to test the effects of dietary fiber, 120 healthy obese adolescents and young adults, age 12-21 (>97th percentile of BMI-for-age) will be recruited to participate in this study.
Recruitment outreach will begin with an email invitation. Parents will be encouraged to call a toll-free number for study information and answer via email. One email will be sent to potential study participants. If there is no response to the email, research staff will call parents up to 5 times and leave 3 messages to introduce the study. Once a parent or potential participant has been reached over the phone, research staff will explain the study and determine interest in participating. If member is interested in participating, research staff will email member the informed consent form (ICF). Participants will sign ICF using Adobe e-Sign web server.
Intervention: Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Using a mobile application, participants will be asked to track bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.
Liquid meal challenge test: The metabolic test will be conducted as two sessions lasting 180 minutes each, before and after the dietary fiber intervention (week 0 and 12). Subjects will participate in the metabolic tests after an overnight fast. Subjects will consume 250 ml of a standard liquid meal replacement shake with sugar added to 75 g of total sugar per meal (equivalent to oral glucose tolerance test used in clinical care). Blood draw will be done through an indwelling catheter in the antecubital vein and blood samples collected into 3 mL Ethylenediaminetetraacetic acid (EDTA) containing tubes at -15, 0, 30, 60, 90, 120, and 180 minutes after administration of the test meal. An additional 5 mL serum tube and urine will be collected at time -15 min. Total blood draw volume for the entire test is 26 mL.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Pasadena, California, United States, 91101
- Kaiser Permanente Clinical Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Kaiser Permanente Southern California (KPSC) member for at least 12 months.
- KPSC members ages 12 to 21 years old.
- KPSC member with >97th percentile of BMI for age.
- Minors with parents whose preferred language is English.
- 18 to 21 year old members whose preferred language is English.
Exclusion Criteria:
- Has diagnosis of serious mental illness and/or cognitive impairment.
- Provider has concerns over participation.
- Minors with parent whose preferred language is not English.
- 18 to 21 year old members whose preferred language is not English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary Fiber Supplement
Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet.
|
Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet.
Participants will be asked to keep a diary assessing bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment
Time Frame: 3 year recruitment period
|
Proportion of patients recruited/consented
|
3 year recruitment period
|
Retention
Time Frame: 3-mo study period
|
Proportion of participants remaining in study
|
3-mo study period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChOBFiber-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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