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Completed

NCT Number: NCT02733263

Resistant Maltodextrin Supplementation: Gastrointestinal Health

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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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

15 g RMD

Dietary Supplement

15 grams of resistant maltodextrin

25 g RMD

Dietary Supplement

25 grams of resistant maltodextrin

0 g RMD

Dietary Supplement

0 grams of resistant maltodextrin

Primary outcomes

  1. Fecal bifidobacteria counts

    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.

Secondary outcomes

  1. Fecal weight

    Time frame: Baseline (Week 0) and Final (Week 3) of each intervention

    Average stool weight and consistency for each intervention

  2. Gastrointestinal Function as a measure of changes in average number of stools

    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.

  3. Immune Status by biomarker sIgA

    Time frame: Baseline (Week 0) and Final (Week 3) of each intervention

    Marker or immune status Secretory Immunoglobulin A (sIgA) using sIgA ELISA

  4. Diet Quality

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • ADM/Matsutani LLC

Registry information

Official study title

Resistant Maltodextrin Supplementation and the Effect on Fecal Bifidobacteria, Bowel Function, Dietary Intake and Quality of Life

Acronym: DEX

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2016
Registry last updated
Mar 2, 2018

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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