Resistant Maltodextrin Supplementation: Gastrointestinal Health (DEX)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: 15 g RMD; Dietary supplement: 25 g RMD; Dietary supplement: 0 g RMD

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin
Experimental: Group 2; Participants will first consume RMD in the the order of 0 g RMD, 25 g RMD, 15 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin
Experimental: Group 3; Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin
Experimental: Group 4; Participants will first consume RMD in the the order of 15 g RMD, 25 g RMD, 0 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin
Experimental: Group 5; Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin
Experimental: Group 6; Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each	Dietary supplement: 15 g RMD; 15 grams of resistant maltodextrin; Dietary supplement: 25 g RMD; 25 grams of resistant maltodextrin; Dietary supplement: 0 g RMD; 0 grams of resistant maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal weight	Average stool weight and consistency for each intervention	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.	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	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.	Week 3 of each intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: ADM/Matsutani LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: gut microbiota; immunity; fiber; diet quality
• Other Study ID Numbers: IRB201501168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No