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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066425
Other study ID # 21839
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2, 2021
Est. completion date June 30, 2023

Study information

Verified date July 2021
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Soluble Corn Fiber
Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks
Maltodextrin
Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign Tate and Lyle Ingredients Americas LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention Accuracy Behavioral performance measured as accuracy (%) during Flanker task 4 weeks
Primary Attention Reaction Time Behavioral performance measured as response time (ms) during Flanker task 4 weeks
Primary P3 Amplitude Amplitude (microvolt) of the P3 ERP waveform assessed during the Flanker task 4 weeks
Primary Event-related potentials Latency (ms) of the P3 ERP waveform assessed during the Flanker task 4 weeks
Primary Relational Memory Accuracy during a spatial reconstruction task 4 weeks
Secondary Gastrointestinal Microbiota Taxonomic compositionprofiles of the gastrointestinal microbiota 4 weeks
Secondary Fecal Metabolites Quantity of short-chain fatty acids in fecal samples 4 weeks
Secondary Mood/Well-being Total score on surveys (POMS, PANAS, SF-36) 4 weeks
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