ObesityNCT03629119
PsylliumRx Dietary Fiber Study
A study testing Dietary Fiber Supplement in people with Obesity and Childhood Obesity, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the… Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity
- What is being tested?
- Dietary Fiber Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Clinical Research Center
Pasadena, California, 91101
About this study
Official title: PsylliumRx: Use of Dietary Fiber in Severely Obese Children to Delay the Onset of Obesity-related Health Conditions - Pilot
The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).
Read the 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.
- Conditions
- Obesity, Childhood Obesity
- Being tested
- Dietary Fiber Supplement
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fiber SupplementDietary 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 asked to keep a diary assessing bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Fiber Supplement | Experimental | Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Receives: Dietary Supplement: Dietary Fiber Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Proportion of patients recruited/consented
Measured: 3 year recruitment period
Retention
Proportion of participants remaining in study
Measured: 3-mo study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start31 Jul 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Recruitment was put on hold in March 2020 due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629119
- Sponsor's protocol ID
- ChOBFiber-P
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2018
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsylliumRx: Use of Dietary Fiber in Severely Obese Children to Delay the Onset of Obesity-related Health Conditions - Pilot
- ClinicalTrials.gov ID
- NCT03629119
- Acronym / sponsor ID
- ChOBFiber-P
- Conditions
- Obesity, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment was put on hold in March 2020 due to COVID
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Fiber Supplement | Experimental | Dietary Supplement: Dietary Fiber SupplementParticipants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fiber SupplementParticipants 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. | Dietary supplement | Dietary Fiber Supplement |
Primary outcome
Recruitment
Time frame: 3 year recruitment period
Proportion of patients recruited/consented
Retention
Time frame: 3-mo study period
Proportion of participants remaining in study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber Supplement in people with Obesity and Childhood Obesity, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 3 year recruitment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.