Recruiting

Soluble Corn Fiber

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT05066425

Conditions

Health

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Soluble Corn Fiber

Maltodextrin

Study Details

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.

Conditions

Health

Study ID

NCT05066425

Start date

Aug 2, 2021

Status verified date

Jul, 2021

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Soluble Corn Fiber

22g Soluble Corn Fiber/day for 4 weeks

placebo comparator: Maltodextrin

22g Maltodextrin/day for 4 weeks

Interventions

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

Primary outcome measure

  • Attention Accuracy [ Time Frame: 4 weeks ]
  • Attention Reaction Time [ Time Frame: 4 weeks ]
  • P3 Amplitude [ Time Frame: 4 weeks ]
  • Event-related potentials [ Time Frame: 4 weeks ]
  • Relational Memory [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

University of Illinois at Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Naiman A Khan, PhD, RD

217-300-2197nakhan2@illinois.edu

Principal Investigator:

Naiman A Khan, PhD, RD

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Oct 4, 2021

Last verified

Jul, 2021

Keywords

  • Microbiota
  • Cognition
  • Fiber

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2021-10-04.