Diet ModificationNCT03722862
Sunfiber and the Microbiota
A study testing Low fiber and High fiber in people with Diet Modification, run by University of Minnesota at 1 site in United States.
Trial summary
The aim of this study is to look at the effect Sunfiber has on the gut microbiota. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Low fiber and High fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 14 Sep 2019
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 20-49 years
- Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.
- Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period.
- Subject is willing to maintain their habitual physical activity patterns throughout the study period.
- Subject has been weight stable within the last 6 months.
- Subject has no health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
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- Low fiber consumer (≤14 g per day)
- Subject is willing to follow study procedures and dietary restrictions (ex: stick to habitual diet, refrain from consuming alcohol 24 hours prior to test days).
- Subject understands study procedures and signs forms providing informed consent to participate in the study.
Who cannot join
- History of a gastrointestinal disorder
- Lactose intolerant
- High fiber consumer (≥15 g per day)
- Use of pre-and probiotics in the past 90 days
- High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo)
- History of psychological illness or conditions that may interfere with subjects ability to understand study directions
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- Use of antibiotics or signs of active systemic infection in the last 6 months. Subjects who are on hypo/hypercaloric diet aiming for weight loss or weight gain
- History or presence of cancer in the prior 2 years (except for non-melanoma skin cancer).
- Currently pregnant, lactating or planning to be pregnant during the study period
- Regular use of dietary supplements (ex: fish oil, riboflavin, etc.), 90 days prior to study inclusion
- Exposure to any non-registered drug product within the last 30 days prior to screening visit
- History of or strong potential for alcohol or substance abuse (within 12 months of screening visit). Alcohol abuse is defined as >60g (men)/40g (women) pure alcohol per day (1.5 L/ 1 l beer resp. 0.75l/0.5l wine).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
The aim of this study is to look at the effect Sunfiber has on the gut microbiota.
Read the detailed description
This is a randomized, double-blind, placebo-controlled crossover study with a 2 week washout period. Healthy volunteers will receive placebo, 4 grams, or 8 grams of Sunfiber in addition to their regular diet. Fecal samples will be collected for measurement of bowl function, including the gut microbiota.
- Conditions
- Diet Modification
- Being tested
- Low fiber, Placebo, High fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fiberDietary supplement
Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses
PlaceboDietary supplement
Participants will receive the placebo/dextrose.
High fiberDietary supplement
Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Healthy volunteers will continue normal healthy diet with a placebo. Receives: Dietary Supplement: Placebo |
| Low fiber | Experimental | Healthy volunteers will be randomized to receive 3 grams of Sunfiber. Receives: Dietary Supplement: Low fiber |
| High fiber | Experimental | Healthy volunteers will be randomized to receive 6 grams of Sunfiber. Receives: Dietary Supplement: High fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Microbiota
Bacterial phyla, genera, and species of bacteria will be detected using real tijme PCR. All abundances will be calculated and presented as relative levels (relative to the total amount of eubacteriausing a universal eubacteria prijer set)
Measured: Day 10
Secondary outcomes (1)
salivary cortisol
Salivary cortisol will be measured using a competitive immunoassay. 25 ul of saliva will be used in each replicate and results will be compared to a standard curve and calculated as ug/dl.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start5 Apr 2019
- Primary completion31 Aug 2019
- Study completion14 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- 3 arm crossover, randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722862
- Sponsor's protocol ID
- STUDY99994204
- Status last verified
- Oct 2019
- First submitted
- 29 Aug 2018
- Last updated
- 4 Oct 2019
- 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunfiber and the Microbiota
- ClinicalTrials.gov ID
- NCT03722862
- Acronym / sponsor ID
- STUDY99994204
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 14 Sep 2019 (actual)
- First posted
- 29 Oct 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 aim of this study is to look at the effect Sunfiber has on the gut microbiota.
Detailed description
This is a randomized, double-blind, placebo-controlled crossover study with a 2 week washout period. Healthy volunteers will receive placebo, 4 grams, or 8 grams of Sunfiber in addition to their regular diet. Fecal samples will be collected for measurement of bowl function, including the gut microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3 arm crossover, randomized
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Dietary Supplement: PlaceboHealthy volunteers will continue normal healthy diet with a placebo. |
| Low fiber | Experimental | Dietary Supplement: Low fiberHealthy volunteers will be randomized to receive 3 grams of Sunfiber. |
| High fiber | Experimental | Dietary Supplement: High fiberHealthy volunteers will be randomized to receive 6 grams of Sunfiber. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female between the ages of 20-49 years
- Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.
- Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period.
- Subject is willing to maintain their habitual physical activity patterns throughout the study period.
- Subject has been weight stable within the last 6 months.
Key exclusion criteria (12 listed)
- History of a gastrointestinal disorder
- Lactose intolerant
- High fiber consumer (≥15 g per day)
- Use of pre-and probiotics in the past 90 days
- High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo)
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 |
|---|---|---|
| Low fiberPartially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses | Dietary supplement | Low fiber |
| PlaceboParticipants will receive the placebo/dextrose. | Dietary supplement | Control Arm |
| High fiberPartially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses | Dietary supplement | High fiber |
Primary outcome
Analysis of Microbiota
Time frame: Day 10
Bacterial phyla, genera, and species of bacteria will be detected using real tijme PCR. All abundances will be calculated and presented as relative levels (relative to the total amount of eubacteriausing a universal eubacteria prijer set)
1 secondary outcome
salivary cortisol
Time frame: Day 10
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 4 Oct 2019.
- 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 Low fiber and High fiber in people with Diet Modification, run by University of Minnesota 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 9 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 4 Oct 2019. 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.
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?
Analysis of Microbiota (time frame: Day 10). 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 4 Oct 2019.