Soluble Corn Fiber for Promoting Executive Function Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Soluble Corn Fiber for Promoting Executive Function Study

Conditions
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Health

Intervention / Treatment
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* Dietary Supplement: Soluble Corn Fiber
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-75 years of age Free of cognitive impairment (Mini-Mental State Examination score of higher than 24) Absence of neurological disease Absence of gastrointestinal diseases Absence of prediabetes or diabetes No color blindness Have normal or corrected-to-normal vision No history of antibiotics or smoking over the past 3 months Agree to refrain from taking pre-or probiotic supplements during the study Agree to inform researchers of any changes in chronic medications during the study Body Mass Index (BMI) between 18.5 to 34.9 kg/m2 Habitual dietary fiber consumption of ≤12g/d (women) and ≤19 g/d (men) based on DHQ II Not consuming an extreme dietary pattern (e.g., vegan, keto, low FODMAP) No allergies to corn or maltodextrin, eggs, peanuts, tree nuts, wheat and soy Agree to maintain habitual dietary patterns throughout the study period Maintain their current level of physical activity Complete all necessary study questionnaires and to provide stool specimens as required. Exclusion Criteria: <45 or >75 years of age Presence of cognitive impairment (Mini-Mental State Examination score of lower than 24) Presence of neurological disease Presence of gastrointestinal diseases Presence of prediabetes or diabetes Color blindness Non normal or uncorrected vision History of antibiotics or smoking over the past 3 months Not agree to refrain from taking pre- or probiotic supplements during the study Not agree to communicate any changes in chronic medications during the study Body Mass Index (BMI) below 18.5 or greater than 34.9 kg/m2 Habitual dietary fiber consumption of >12g/d (women) and >19 g/d (men) based on DHQ II Consuming an extreme dietary pattern (e.g., vegan, keto, low FODMAP) Allergies to corn and/or maltodextrin Not agree to maintain habitual dietary patterns throughout the study period Not agree to maintain their current level of physical activity Not agree to complete all necessary study questionnaires and to provide stool specimens as required.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soluble Corn Fiber<br>22g Soluble Corn Fiber/day for 4 weeks | Dietary Supplement: Soluble Corn Fiber<br>* Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks<br>|
| Placebo Comparator: Maltodextrin<br>22g Maltodextrin/day for 4 weeks | Dietary Supplement: Maltodextrin<br>* Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 4 weeks | 
| Mood/Well-being | Total score on surveys (POMS, PANAS, SF-36) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Cognition, Fiber