Health
Conditions
Keywords
Microbiota, Cognition, Fiber
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoluble Corn Fiber
Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks
DIETARY_SUPPLEMENTMaltodextrin
Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks
Sponsors
Tate and Lyle Ingredients Americas LLC
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 45-75 years of age 2. Free of cognitive impairment (Mini-Mental State Examination score of higher than 24) 3. Absence of neurological disease 4. Absence of gastrointestinal diseases 5. Absence of prediabetes or diabetes 6. No color blindness 7. Have normal or corrected-to-normal vision 8. No history of antibiotics or smoking over the past 3 months 9. Agree to refrain from taking pre-or probiotic supplements during the study 10. Agree to inform researchers of any changes in chronic medications during the study 11. Body Mass Index (BMI) between 18.5 to 34.9 kg/m2 12. Habitual dietary fiber consumption of ≤12g/d (women) and ≤19 g/d (men) based on DHQ II 13. Not consuming an extreme dietary pattern (e.g., vegan, keto, low FODMAP) 14. No allergies to corn or maltodextrin, eggs, peanuts, tree nuts, wheat and soy 15. Agree to maintain habitual dietary patterns throughout the study period 16. Maintain their current level of physical activity 17. Complete all necessary study questionnaires and to provide stool specimens as required.
Exclusion criteria
1. \<45 or \>75 years of age 2. Presence of cognitive impairment (Mini-Mental State Examination score of lower than 24) 3. Presence of neurological disease 4. Presence of gastrointestinal diseases 5. Presence of prediabetes or diabetes 6. Color blindness 7. Non normal or uncorrected vision 8. History of antibiotics or smoking over the past 3 months 9. Not agree to refrain from taking pre- or probiotic supplements during the study 10. Not agree to communicate any changes in chronic medications during the study 11. Body Mass Index (BMI) below 18.5 or greater than 34.9 kg/m2 12. Habitual dietary fiber consumption of \>12g/d (women) and \>19 g/d (men) based on DHQ II 13. Consuming an extreme dietary pattern (e.g., vegan, keto, low FODMAP) 14. Allergies to corn and/or maltodextrin 15. Not agree to maintain habitual dietary patterns throughout the study period 16. Not agree to maintain their current level of physical activity 17. Not agree to complete all necessary study questionnaires and to provide stool specimens as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relational Memory | 4 weeks | Accuracy during a spatial reconstruction task |
| Attention Reaction Time | 4 weeks | Behavioral performance measured as response time (ms) during Flanker task |
| P3 Amplitude | 4 weeks | Amplitude (microvolt) of the P3 ERP waveform assessed during the Flanker task |
| Event-related potentials | 4 weeks | Latency (ms) of the P3 ERP waveform assessed during the Flanker task |
| Attention Accuracy | 4 weeks | Behavioral performance measured as accuracy (%) during Flanker task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Metabolites | 4 weeks | Quantity of short-chain fatty acids in fecal samples |
| Mood/Well-being | 4 weeks | Total score on surveys (POMS, PANAS, SF-36) |
| Gastrointestinal Microbiota | 4 weeks | Taxonomic compositionprofiles of the gastrointestinal microbiota |
Countries
United States
Outcome results
None listed