Resistant Maltodextrin Supplementation: Gastrointestinal Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 15 g RMD
* Dietary Supplement: 25 g RMD
* Dietary Supplement: 0 g RMD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|
| Experimental: Group 2<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|
| Experimental: Group 3<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|
| Experimental: Group 4<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|
| Experimental: Group 5<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|
| Experimental: Group 6<br>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<br>* 15 grams of resistant maltodextrin<br>Dietary Supplement: 25 g RMD<br>* 25 grams of resistant maltodextrin<br>Dietary Supplement: 0 g RMD<br>* 0 grams of resistant maltodextrin<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, fiber, diet quality, immunity