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Resistant Maltodextrin Supplementation: Gastrointestinal Health (DEX)

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ClinicalTrials.gov Identifier: NCT02733263
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
ADM/Matsutani LLC
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 15 g RMD Dietary Supplement: 25 g RMD Dietary Supplement: 0 g RMD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Resistant Maltodextrin Supplementation and the Effect on Fecal Bifidobacteria, Bowel Function, Dietary Intake and Quality of Life
Study Start Date : May 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733263


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
ADM/Matsutani LLC
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02733263     History of Changes
Other Study ID Numbers: IRB201501168
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
gut microbiota
fiber
diet quality
immunity