Resistant Maltodextrin Supplementation: Gastrointestinal Health
DEX
1 other identifier
interventional
64
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 2, 2018
February 1, 2018
2 months
March 25, 2016
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (Week 0) and Final (Week 3) of each intervention
Secondary Outcomes (4)
Fecal weight
Baseline (Week 0) and Final (Week 3) of each intervention
Gastrointestinal Function as a measure of changes in average number of stools
Baseline (Week 0) and Final (Week 3) of each intervention
Immune Status by biomarker sIgA
Baseline (Week 0) and Final (Week 3) of each intervention
Diet Quality
Week 3 of each intervention
Study Arms (6)
Group 1
EXPERIMENTALParticipants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each
Group 2
EXPERIMENTALParticipants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each
Group 3
EXPERIMENTALParticipants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each
Group 4
EXPERIMENTALParticipants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each
Group 5
EXPERIMENTALParticipants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each
Group 6
EXPERIMENTALParticipants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each
Interventions
15 grams of resistant maltodextrin
25 grams of resistant maltodextrin
0 grams of resistant maltodextrin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- ADM/Matsutani LLCcollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Bobbi Langkamp-Henken, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 11, 2016
Study Start
May 1, 2016
Primary Completion
June 30, 2016
Study Completion
November 1, 2016
Last Updated
March 2, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share