HealthyDEXNCT02733263
Resistant Maltodextrin Supplementation: Gastrointestinal Health
A study testing 15 g RMD, 25 g RMD and 0 g RMD in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk by enhancing growth of specific microbial populations; however the effect of RMD on bifidobacteria and total fecal weight is not clear. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 15 g RMD, 25 g RMD and 0 g RMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18.5 to <30 kg/m2
- Usual fiber intake of <19 g/d for males and 13 g/d for females based on Food Frequency Questionnaire (FFQ) such as the NutritionQuest Fruit/Vegetable/Fiber Screener.
- Willing to complete daily and weekly questionnaires, 20 dietary recalls, and 15 stool collection days over approximately 18 weeks
- Willing to drink the study supplements for 3 weeks for each of the three intervention periods
- Willing to discontinue any prebiotic, fiber, or probiotic supplements or foods containing probiotics (e.g., yogurts with live, active cultures)
- Internet access for the duration of the protocol to complete online questionnaires
- On average you have 6 or more stools but fewer than 12
Who cannot join
- Does not meet above criteria
- Dietary fiber intake greater than half the adequate intake (AI) based on Automated Self-Administered Diet History (ASA24) (http://riskfactor.cancer.gov/tools/instruments/asa24/) dietary intake data collected during run-in period:
- Females with a dietary fiber ≥13 g/d
- Males with a dietary fiber ≥19 g/d
- Antibiotic use within 2 months from providing the screening stool sample
- Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than Gastroesophageal Reflux Disease (GERD), constipation, or diverticular disease
- Purposeful strenuous exercise of >300 minutes per week on average
- Women who are lactating or know they are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistant Maltodextrin Supplementation and the Effect on Fecal Bifidobacteria, Bowel Function, Dietary Intake and Quality of Life
Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk by enhancing growth of specific microbial populations; however the effect of RMD on bifidobacteria and total fecal weight is not clear. The purpose of this research study is to determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce beneficial changes in gastrointestinal function, the fecal microbiota profile (increased number of healthy bacteria in stool) and immune processes resulting in improved quality of life.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study. After obtaining informed consent, participants will be randomized to either consume 0, 15 or 25 grams of resistant maltodextrin (RMD) during the first arm of the study. During the first intervention period, participants will consume the RMD everyday for 3 weeks. After a 2-week post intervention period, participants will be crossed to one of the other treatments for 3 weeks, followed by a 2-week post intervention and then receive the final intervention for 3 weeks.
Participants will complete daily questionnaires and weekly gastrointestinal symptom questionnaires during the intervention and post-intervention periods. Stool samples will be collected at the baseline and final time points of each intervention. Dietary intake will also be assessed weekly during each intervention period.
- Conditions
- Healthy
- Being tested
- 15 g RMD, 25 g RMD, 0 g RMD
- Keywords
- gut microbiota, fiber, diet quality, immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 g RMDDietary supplement
15 grams of resistant maltodextrin
25 g RMDDietary supplement
25 grams of resistant maltodextrin
0 g RMDDietary supplement
0 grams of resistant maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
| Group 2 | Experimental | Participants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
| Group 3 | Experimental | Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
| Group 4 | Experimental | Participants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
| Group 5 | Experimental | Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
| Group 6 | Experimental | Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each Receives: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal bifidobacteria counts
The mean of the change between baseline and final time points in stool bifidobacteria counts [log(CFU)] was compared for each study arm.
Measured: Baseline (Week 0) and Final (Week 3) of each intervention
Secondary outcomes (4)
Fecal weight
Average stool weight and consistency for each intervention
Measured: Baseline (Week 0) and Final (Week 3) of each intervention
Gastrointestinal Function as a measure of changes in average number of stools
Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Measured: Baseline (Week 0) and Final (Week 3) of each intervention
Immune Status by biomarker sIgA
Marker or immune status Secretory Immunoglobulin A (sIgA) using sIgA ELISA
Measured: Baseline (Week 0) and Final (Week 3) of each intervention
Diet Quality
Six dietary recalls occurred per study intervention, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).
High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.
Measured: Week 3 of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion30 Jun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- ADM/Matsutani LLC
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733263
- Sponsor's protocol ID
- IRB201501168
- Acronym
- DEX
- Status last verified
- Feb 2018
- First submitted
- 25 Mar 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Maltodextrin Supplementation and the Effect on Fecal Bifidobacteria, Bowel Function, Dietary Intake and Quality of Life
- ClinicalTrials.gov ID
- NCT02733263
- Acronym / sponsor ID
- DEX / IRB201501168
- Conditions
- Healthy
- Keywords
- gut microbiota, fiber, diet quality, immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- ADM/Matsutani LLC
- Study start
- May 2016
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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.
Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk by enhancing growth of specific microbial populations; however the effect of RMD on bifidobacteria and total fecal weight is not clear. The purpose of this research study is to determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce beneficial changes in gastrointestinal function, the fecal microbiota profile (increased number of healthy bacteria in stool) and immune processes resulting in improved quality of life.
Detailed description
This is a randomized, double-blind, placebo-controlled study. After obtaining informed consent, participants will be randomized to either consume 0, 15 or 25 grams of resistant maltodextrin (RMD) during the first arm of the study. During the first intervention period, participants will consume the RMD everyday for 3 weeks. After a 2-week post intervention period, participants will be crossed to one of the other treatments for 3 weeks, followed by a 2-week post intervention and then receive the final intervention for 3 weeks.
Participants will complete daily questionnaires and weekly gastrointestinal symptom questionnaires during the intervention and post-intervention periods. Stool samples will be collected at the baseline and final time points of each intervention. Dietary intake will also be assessed weekly during each intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each |
| Group 2 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each |
| Group 3 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each |
| Group 4 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each |
| Group 5 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each |
| Group 6 | Experimental | Dietary Supplement: 15 g RMD, Dietary Supplement: 25 g RMD, Dietary Supplement: 0 g RMDParticipants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) of 18.5 to <30 kg/m2
- Usual fiber intake of <19 g/d for males and 13 g/d for females based on Food Frequency Questionnaire (FFQ) such as the NutritionQuest Fruit/Vegetable/Fiber Screener.
- Willing to complete daily and weekly questionnaires, 20 dietary recalls, and 15 stool collection days over approximately 18 weeks
- Willing to drink the study supplements for 3 weeks for each of the three intervention periods
- Willing to discontinue any prebiotic, fiber, or probiotic supplements or foods containing probiotics (e.g., yogurts with live, active cultures)
Key exclusion criteria (8 listed)
- Does not meet above criteria
- Dietary fiber intake greater than half the adequate intake (AI) based on Automated Self-Administered Diet History (ASA24) (http://riskfactor.cancer.gov/tools/instruments/asa24/) dietary intake data collected during run-in period:
- Antibiotic use within 2 months from providing the screening stool sample
- Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than Gastroesophageal Reflux Disease (GERD), constipation, or diverticular disease
- Purposeful strenuous exercise of >300 minutes per week on average
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 |
|---|---|---|
| 15 g RMD15 grams of resistant maltodextrin | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| 25 g RMD25 grams of resistant maltodextrin | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| 0 g RMD0 grams of resistant maltodextrin | Dietary supplement | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Fecal bifidobacteria counts
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
The mean of the change between baseline and final time points in stool bifidobacteria counts [log(CFU)] was compared for each study arm.
4 secondary outcomes
Fecal weight
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Gastrointestinal Function as a measure of changes in average number of stools
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Immune Status by biomarker sIgA
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Diet Quality
Time frame: Week 3 of each intervention
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 2 Mar 2018.
- 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.
Bobbi Langkamp-Henken, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 g RMD, 25 g RMD and 0 g RMD in people with Healthy, run by University of Florida 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 7 inclusion and 8 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 2 Mar 2018. 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?
Fecal bifidobacteria counts (time frame: Baseline (Week 0) and Final (Week 3) of each intervention). 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 2 Mar 2018; AzTrials last refreshed its copy on 3 Nov 2026.