Bariatric Surgery CandidateFSPBNCT05653648
Fiber Supplementation After Bariatric Surgery
A study testing Potato starch in people with Bariatric Surgery Candidate, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Potato starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 28 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Bariatric surgery at Dartmouth Medical Center
- Daily protein intake ≥ 60 grams
- Daily fluid intake ≥ 48 fl oz.
Who cannot join
- > 550 lbs at bariatric surgery date.
- Allergies to potato starches.
- Surgical complications per bariatric team members
- Individuals who cannot speak and/or write in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Testing the Feasibility of Resistant Starch From Potatoes to Modify Short-chain Fatty Acid Levels After Bariatric Surgery
Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
Read the detailed description
Despite the successful weight loss associated with bariatric surgery, epidemiology studies have observed conflicting associations between bariatric surgery and incidence of colorectal cancer (CRC), potentially suggesting an increased risk of CRC post-surgery. The investigators have identified a potential mechanism between bariatric surgery and CRC via profiling dietary intake, gut microbiota colonization, and short-chain fatty acid (SCFA) production, including acetate, propionate, and butyrate. They have demonstrated a decrease in SCFA after bariatric surgery. As intestinal SCFAs inhibit colon cancer cell proliferation, these results may suggest a mechanism linking bariatric surgery, SCFA levels, and CRC.
The objective of this protocol is to implement a 30-day fiber supplement, made from potato starch, as previous studies have successfully demonstrated that a resistant starch supplement increases intestinal SCFAs in healthy populations. The resistant starch supplement will be initiated 90-days post-bariatric surgery, which is when fiber supplements are tolerated. Fecal samples will be collected pre- and post-supplement and a targeted liquid chromatography/mass spectrometry platform will quantify levels of SCFAs. As SCFA levels have been associated with reduced hunger in other studies, the investigators will determine if hunger levels are altered in response to the supplement. The proposed study is described in the following aims:
Specific Aim 1. Assess compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients.
Specific Aim 2. Determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
Exploratory Aim. Determine if there are changes in dietary intake, appetite, and satiety in response to the dosages of potato starch.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Potato starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato starchDietary supplement
Participants will consume 24 grams (days 1-15) and 48 grams (days 16-30) of potato starch. Potato starch is a type 2 resistant starch that is available over the counter.
| Study group | Role | What they receive |
|---|---|---|
| Potato Starch Supplement | Experimental | Participants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30. Receives: Dietary Supplement: Potato starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Test gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients. Gastrointestinal tolerance will be measured using the GSRS survey (Svedlund et al, Digestive Diseases and Sciences, 1988). Statistics will use paired t-test.
Measured: 30 days
Secondary outcomes (1)
Short-chain fatty acid
Test changes in short-chain fatty acid levels from stool samples after a 30-day dose of potato starch in bariatric patients. Statistics will use paired t-test.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start13 Feb 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
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 Bariatric Surgery CandidateStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Meijer, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653648
- Sponsor's protocol ID
- Study02001775
- Acronym
- FSPB
- Status last verified
- Feb 2024
- First submitted
- 6 Dec 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metabolomics data will be uploaded to Metabolomics Workbench one year after receiving data. Clinical variables, dietary data, and survey responses will be available upon request to PI.
Publications
Moser B, Saxby SM, Lebby S, Letendre JD, Lange S, Mendez MA, Trus TL, Honigsberg E, Billmeier SE, Gilbert-Diamond D, Dao MC, Meijer JL. Daily fiber supplementation after bariatric surgery demonstrates tolerability and influence on the fecal gut microbiome. Front Nutr. 2026 Aug 19;13:1912097. doi: 10.3389/fnut.2026.1912097. eCollection 2026.
PubMed 42689141
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Resistant Starch From Potatoes to Modify Short-chain Fatty Acid Levels After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05653648
- Acronym / sponsor ID
- FSPB / Study02001775
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Dec 2022 (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.
Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
Detailed description
Despite the successful weight loss associated with bariatric surgery, epidemiology studies have observed conflicting associations between bariatric surgery and incidence of colorectal cancer (CRC), potentially suggesting an increased risk of CRC post-surgery. The investigators have identified a potential mechanism between bariatric surgery and CRC via profiling dietary intake, gut microbiota colonization, and short-chain fatty acid (SCFA) production, including acetate, propionate, and butyrate. They have demonstrated a decrease in SCFA after bariatric surgery. As intestinal SCFAs inhibit colon cancer cell proliferation, these results may suggest a mechanism linking bariatric surgery, SCFA levels, and CRC.
The objective of this protocol is to implement a 30-day fiber supplement, made from potato starch, as previous studies have successfully demonstrated that a resistant starch supplement increases intestinal SCFAs in healthy populations. The resistant starch supplement will be initiated 90-days post-bariatric surgery, which is when fiber supplements are tolerated. Fecal samples will be collected pre- and post-supplement and a targeted liquid chromatography/mass spectrometry platform will quantify levels of SCFAs. As SCFA levels have been associated with reduced hunger in other studies, the investigators will determine if hunger levels are altered in response to the supplement. The proposed study is described in the following aims:
Specific Aim 1. Assess compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients.
Specific Aim 2. Determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
Exploratory Aim. Determine if there are changes in dietary intake, appetite, and satiety in response to the dosages of potato starch.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potato Starch Supplement | Experimental | Dietary Supplement: Potato starchParticipants will consume a 24 grams of potato starch on Days 1-15 and 48 grams of potato starch on Days 16-30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Bariatric surgery at Dartmouth Medical Center
- Daily protein intake ≥ 60 grams
- Daily fluid intake ≥ 48 fl oz.
Key exclusion criteria (4 listed)
- > 550 lbs at bariatric surgery date.
- Allergies to potato starches.
- Surgical complications per bariatric team members
- Individuals who cannot speak and/or write in 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 |
|---|---|---|
| Potato starchParticipants will consume 24 grams (days 1-15) and 48 grams (days 16-30) of potato starch. Potato starch is a type 2 resistant starch that is available over the counter. | Dietary supplement | Potato Starch Supplement |
Primary outcome
Gastrointestinal tolerance
Time frame: 30 days
Test gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients. Gastrointestinal tolerance will be measured using the GSRS survey (Svedlund et al, Digestive Diseases and Sciences, 1988). Statistics will use paired t-test.
1 secondary outcome
Short-chain fatty acid
Time frame: 30 days
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 29 Feb 2024.
- Derived from this study: PubMed 42689141Moser B, Saxby SM, Lebby S, Letendre JD, Lange S, Mendez MA, Trus TL, Honigsberg E, Billmeier SE, Gilbert-Diamond D, Dao MC, Meijer JL. Daily fiber supplementation after bariatric surgery demonstrates tolerability and influence on the fecal gut microbiome. Front Nutr. 2026 Aug 19;13:1912097. doi: 10.3389/fnut.2026.1912097. eCollection 2026.
- Individual participant dataSharing planned: Yes. Metabolomics data will be uploaded to Metabolomics Workbench one year after receiving data. Clinical variables, dietary data, and survey responses will be available upon request to PI.
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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 Potato starch in people with Bariatric Surgery Candidate, run by Dartmouth-Hitchcock Medical Center 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 4 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: finished, as of the sponsor's last update on 29 Feb 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?
Gastrointestinal tolerance (time frame: 30 days). 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 NCT05653648, 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 29 Feb 2024.