Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ADM/Matsutani LLC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will first consume in the the order of 0 g RMD, 15 g RMD, 25 g RMD for 3 weeks each |
|
| Group 2 | Experimental | 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 | Experimental | Participants will first consume RMD in the the order of 15 g RMD, 0 g RMD, 25 g RMD for 3 weeks each |
|
| Group 4 | Experimental | 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 | Experimental | Participants will first consume RMD in the the order of 25 g RMD, 15 g RMD, 0 g RMD for 3 weeks each |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 g RMD | Dietary Supplement | 15 grams of resistant maltodextrin |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Group 6 | Experimental | Participants will first consume RMD in the the order of 25 g RMD, 0 g RMD, 15 g RMD for 3 weeks each |
|
| 25 g RMD | Dietary Supplement | 25 grams of resistant maltodextrin |
|
| 0 g RMD | Dietary Supplement | 0 grams of resistant maltodextrin |
|
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 |