Soluble Corn Fiber for Promoting Executive Function Study (SCOPE)

University of Illinois at Urbana-Champaign

Status

Unknown

Conditions

Health

Treatments

Dietary Supplement: Soluble Corn Fiber

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT05066425

21839

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.