Resistant Maltodextrin Supplementation: Gastrointestinal Health

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02733263

Run by

University of Florida

People needed

64

Starts

2016-05-01

Expected to finish

2016-11-01

Last updated by the study team

2018-03-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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