University of Florida
Gainesville, Florida, 32611, United States
NCT Number: NCT02733263
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.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15 grams of resistant maltodextrin
25 grams of resistant maltodextrin
0 grams of resistant maltodextrin
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.
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Average stool weight and consistency for each intervention
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.
Time frame: Baseline (Week 0) and Final (Week 3) of each intervention
Marker or immune status Secretory Immunoglobulin A (sIgA) using sIgA ELISA
Time frame: Week 3 of each intervention
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.
University of Florida
Other
Resistant Maltodextrin Supplementation and the Effect on Fecal Bifidobacteria, Bowel Function, Dietary Intake and Quality of Life
Acronym: DEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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