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| Name | Class |
|---|---|
| Tate and Lyle Ingredients Americas LLC | UNKNOWN |
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The overarching aim of this study is to test the influence of daily consumption of a soluble corn fiber (SCF) known i.e., PROMITOR® Soluble Fibre™ for cognitive function among middle and older-aged adults.
Although regular consumption of soluble dietary fiber has been shown to support multiple markers of gastrointestinal and physical health, the effects of regular fiber consumption for promoting cognitive health remain unclear. Additionally, the GI microbiota-dependent mechanisms by which dietary fiber may impact markers of cognitive function remain understudied. Thus, the overarching aim of this study is to test the influence of daily consumption of a soluble corn fiber (SCF) known i.e., PROMITOR® Soluble Fibre™ for cognitive function among middle and older-aged adults. The primary hypothesis is that daily consumption of dietary fiber over a period of 4 weeks will significantly improve executive function. The secondary hypothesis is that the influence of SCF on cognitive outcomes will be mediated by improvement in GI bacterial taxa and fermentation-end product profiles. These hypotheses will be tested by conducting a 4 week randomized, double-blind, placebo-controlled cross-over study among healthy, i.e., free-living cognitively intact middle-aged and older adults between45-75 years of age. This work is significant because most Americans do not meet their recommended dietary fiber intake and there is a growing interest in understanding the potential benefits of consuming dietary fiber for broader health outcomes including both gastrointestinal and cognitive health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soluble Corn Fiber | Experimental | 22g Soluble Corn Fiber/day for 4 weeks |
|
| Maltodextrin | Placebo Comparator | 22g Maltodextrin/day for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soluble Corn Fiber | Dietary Supplement | Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attention Accuracy | Behavioral performance measured as accuracy (%) during Flanker task | 4 weeks |
| Attention Reaction Time | Behavioral performance measured as response time (ms) during Flanker task | 4 weeks |
| P3 Amplitude | Amplitude (microvolt) of the P3 ERP waveform assessed during the Flanker task | 4 weeks |
| Event-related potentials | Latency (ms) of the P3 ERP waveform assessed during the Flanker task | 4 weeks |
| Relational Memory | Accuracy during a spatial reconstruction task | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Microbiota | Taxonomic compositionprofiles of the gastrointestinal microbiota | 4 weeks |
| Fecal Metabolites | Quantity of short-chain fatty acids in fecal samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Urbana-Champaign | Recruiting | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41825740 | Derived | Alvarado DA, Holthaus TA, Martell S, Southey NL, Atallah M, Sarma R, Revilla D, Brown M, Mehta T, Khan NA, Holscher HD. Effects of Soluble Corn Fiber Consumption on Executive Functions and Gut Microbiota in Middle to Older Age Adults: A Randomized Controlled Crossover Trial. J Nutr. 2026 May;156(5):101473. doi: 10.1016/j.tjnut.2026.101473. Epub 2026 Mar 11. |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks |
|
| 4 weeks |
| Mood/Well-being | Total score on surveys (POMS, PANAS, SF-36) | 4 weeks |