Weight Gain TrajectoryPhase 4NCT04498455
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
A Phase 4 study testing Prebiotin in people with Weight Gain Trajectory and Metabolic Syndrome, run by Baylor University at 1 site in United States.
Trial summary
A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Weight Gain Trajectory, Metabolic Syndrome
- What is being tested?
- Prebiotin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 15 Feb 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently a resident in training at the Family Health Center in their first year.
Who cannot join
- Pregnancy
- Currently on prescribed metformin or NSAIDS
- A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
- Known allergy to the supplement, placebo, or provided meal replacements
- Antibiotic use within the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.
Read the detailed description
This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber [Prebiotin] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.
- Conditions
- Weight Gain Trajectory, Metabolic Syndrome
- Being tested
- Prebiotin
- Keywords
- Fiber, Microbiome, Metabolism
- Medical subject headings
- Body-Weight Trajectory, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebiotinDietary supplement
Fructo-oligosaccharide dietary supplement powder
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Receives: Dietary Supplement: Prebiotin |
| Prebiotin | Active comparator | Dietary Supplement: Prebiotin (oligofructose enriched inulin) Receives: Dietary Supplement: Prebiotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start30 Sep 2018
- Primary completion14 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Gain TrajectoryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled trial of a fiber supplement \[Prebiotin\] compared to placebo \[maltodextrin\]
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leigh Greathouse, Baylor University
- Investigators
- LesLee Funderburk, Ph.D., Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498455
- Sponsor's protocol ID
- 1255329-5
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
- ClinicalTrials.gov ID
- NCT04498455
- Acronym / sponsor ID
- 1255329-5
- Conditions
- Weight Gain Trajectory, Metabolic Syndrome
- Keywords
- Fiber, Microbiome, Metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 4 Aug 2020 (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.
A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.
Detailed description
This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber [Prebiotin] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PrebiotinDietary Supplement: Placebo |
| Prebiotin | Active comparator | Dietary Supplement: PrebiotinDietary Supplement: Prebiotin (oligofructose enriched inulin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Currently a resident in training at the Family Health Center in their first year.
Key exclusion criteria (5 listed)
- Pregnancy
- Currently on prescribed metformin or NSAIDS
- A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
- Known allergy to the supplement, placebo, or provided meal replacements
- Antibiotic use within the last 3 months.
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 |
|---|---|---|
| PrebiotinFructo-oligosaccharide dietary supplement powder | Dietary supplement | Placebo, Prebiotin |
Primary outcome
Change in body weight
Time frame: 12 weeks
The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Study analysisLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share individual data
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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.
LesLee Funderburk, Ph.D. principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prebiotin in people with Weight Gain Trajectory and Metabolic Syndrome, run by Baylor University 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 17 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in body weight (time frame: 12 weeks). 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 17 Aug 2020.