Resistant Maltodextrin Supplementation: Gastrointestinal Health

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 15 g RMD; Dietary Supplement: 25 g RMD; Dietary Supplement: 0 g RMD

• Registration Number: NCT02733263
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Study Start: 2016-05
• Primary Completion: 2016-06-30
• Study Completion: 2016-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	15 g RMD	Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each
Group 2	15 g RMD	Participants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each
Group 1	0 g RMD	Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each
Group 2	0 g RMD	Participants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each
Group 3	25 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each
Group 5	25 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each
Group 6	25 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each
Group 3	0 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each
Group 1	25 g RMD	Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each
Group 2	25 g RMD	Participants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each
Group 4	15 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each
Group 4	0 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each
Group 5	0 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each
Group 3	15 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each
Group 5	15 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each
Group 6	15 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each
Group 4	25 g RMD	Participants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each
Group 6	0 g RMD	Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each

Primary Outcome Measures

Name	Time	Method
Fecal bifidobacteria counts	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.

Secondary Outcome Measures

Name	Time	Method
Fecal weight	Baseline (Week 0) and Final (Week 3) of each intervention	Average stool weight and consistency for each intervention
Gastrointestinal Function as a measure of changes in average number of stools	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.
Diet Quality	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.
Immune Status by biomarker sIgA	Baseline (Week 0) and Final (Week 3) of each intervention	Marker or immune status Secretory Immunoglobulin A (sIgA) using sIgA ELISA

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States