MicrobiotaFDRNCT04729816
Assessing the Dose Response of a Lead Fiber Snack Prototype
A study of Microbiota and Gastrointestinal Microbiome, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Gastrointestinal Microbiome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 15 Nov 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥25.0 and ≤35.0 kg/m2
Who cannot join
- Previous bariatric surgery
- Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or -cardiovascular disease)
- Cancer or cancer that has been in remission for less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
- Pregnant or lactating women
Show all 12Show fewer
- Use of medications that are known to affect the study outcome measures
- Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
- Bowel movements less than 3 times per week
- Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
- Persons that are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Assessing the Dose Response of a Lead Fiber Snack Prototype on the Gut Microbiome and Host Metabolome and Proteome
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes.
Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.
- Conditions
- Microbiota, Gastrointestinal Microbiome
- Being tested
- Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.Other
Phase 1: Participants will be provided with a high fat/low fiber diet in the form of packed out meals and snacks for 10 days in total (days 2-11 and days 54-63)
Phase 2: Participants will be provided with the high fat/low fiber diet, plus 1 daily fiber-blend snack serving from days 12-25
Phase 3: Participants will receive 2 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 26-39.
Phase 4: Participants will receive 3 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 40-53.
Phase 5: Participants will return to the unsupplemented high fat/low fiber diet for days 54-63
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | All participants will stay weight stable while undergoing 5 phases of a dietary intervention that lasts 62 days. Receives: Other: Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the gut microbiota/microbiome
Changes to the gut microbiota/microbiome as a function of background diet and fiber dose escalation using culture independent methods. Investigators will use higher order singular value decomposition (HOSVD) to analyze changes in the gut microbiome - including the representation of carbohydrate-active enzyme genes (CAZymes), metabolic pathways and Amplicon Sequence Variants (ASVs) in shotgun sequencing datasets generated from fecal DNA collected at the beginning and end of each dose escalation phase.
Measured: Stool samples will be collected periodically from day 1 through the final day of the 63-day study
Changes in the plasma proteome/metabolome
Changes in the plasma proteome/metabolome (aptamer-based proteomics/mass spectrometry) as a function of fiber dose escalation and their correlation with features of the gut microbiome using cross-correlation singular value decomposition (CC-SVD).
Measured: Fasted blood draws will be collected at day 1, day 11, day 25, day 39, day 53, and day 63. Stool samples will be collected periodically from day 1 through the final day of the 63-day study
Change in plasma lipid profile
Changes in the plasma lipid profile as a function of background diet and fiber dose escalation as assessed by complete metabolic and lipid panels.
Measured: Fasted blood draws will be collected at screening, day 11, day 25, day 39, day 53, and day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start22 Feb 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Fiber supplementation increasing by 10.2g per 2-week dosing period, from 0 to 30.6g supplemental fiber at the end of the dose escalation.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729816
- Sponsor's protocol ID
- 202010046
- Acronym
- FDR
- Status last verified
- Dec 2024
- First submitted
- 9 Nov 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patnode ML, Beller ZW, Han ND, Cheng J, Peters SL, Terrapon N, Henrissat B, Le Gall S, Saulnier L, Hayashi DK, Meynier A, Vinoy S, Giannone RJ, Hettich RL, Gordon JI. Interspecies Competition Impacts Targeted Manipulation of Human Gut Bacteria by Fiber-Derived Glycans. Cell. 2019 Sep 19;179(1):59-73.e13. doi: 10.1016/j.cell.2019.08.011.
PubMed 31539500
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Dose Response of a Lead Fiber Snack Prototype on the Gut Microbiome and Host Metabolome and Proteome
- ClinicalTrials.gov ID
- NCT04729816
- Acronym / sponsor ID
- FDR / 202010046
- Conditions
- Microbiota, Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 29 Jan 2021 (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.
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes.
Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fiber supplementation increasing by 10.2g per 2-week dosing period, from 0 to 30.6g supplemental fiber at the end of the dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.All participants will stay weight stable while undergoing 5 phases of a dietary intervention that lasts 62 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI ≥25.0 and ≤35.0 kg/m2
Key exclusion criteria (12 listed)
- Previous bariatric surgery
- Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or -cardiovascular disease)
- Cancer or cancer that has been in remission for less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
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 |
|---|---|---|
| Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.Phase 1: Participants will be provided with a high fat/low fiber diet in the form of packed out meals and snacks for 10 days in total (days 2-11 and days 54-63) Phase 2: Participants will be provided with the high fat/low fiber diet, plus 1 daily fiber-blend snack serving from days 12-25 Phase 3: Participants will receive 2 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 26-39. Phase 4: Participants will receive 3 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 40-53. Phase 5: Participants will return to the unsupplemented high fat/low fiber diet for days 54-63 | Other | Dietary Intervention |
Primary outcome
Changes to the gut microbiota/microbiome
Time frame: Stool samples will be collected periodically from day 1 through the final day of the 63-day study
Changes to the gut microbiota/microbiome as a function of background diet and fiber dose escalation using culture independent methods. Investigators will use higher order singular value decomposition (HOSVD) to analyze changes in the gut microbiome - including the representation of carbohydrate-active enzyme genes (CAZymes), metabolic pathways and Amplicon Sequence Variants (ASVs) in shotgun sequencing datasets generated from fecal DNA collected at the beginning and end of each dose escalation phase.
Changes in the plasma proteome/metabolome
Time frame: Fasted blood draws will be collected at day 1, day 11, day 25, day 39, day 53, and day 63. Stool samples will be collected periodically from day 1 through the final day of the 63-day study
Changes in the plasma proteome/metabolome (aptamer-based proteomics/mass spectrometry) as a function of fiber dose escalation and their correlation with features of the gut microbiome using cross-correlation singular value decomposition (CC-SVD).
Change in plasma lipid profile
Time frame: Fasted blood draws will be collected at screening, day 11, day 25, day 39, day 53, and day 63
Changes in the plasma lipid profile as a function of background diet and fiber dose escalation as assessed by complete metabolic and lipid panels.
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 27 Dec 2024.
- Background: PubMed 31539500Patnode ML, Beller ZW, Han ND, Cheng J, Peters SL, Terrapon N, Henrissat B, Le Gall S, Saulnier L, Hayashi DK, Meynier A, Vinoy S, Giannone RJ, Hettich RL, Gordon JI. Interspecies Competition Impacts Targeted Manipulation of Human Gut Bacteria by Fiber-Derived Glycans. Cell. 2019 Sep 19;179(1):59-73.e13. doi: 10.1016/j.cell.2019.08.011.
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Microbiota and Gastrointestinal Microbiome, run by Washington University School of Medicine 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 12 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 27 Dec 2024. 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?
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?
Changes to the gut microbiota/microbiome (time frame: Stool samples will be collected periodically from day 1 through the final day of the 63-day study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729816, which also lists 1 linked publication.
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 27 Dec 2024.