Soluble Corn Fiber for Promoting Executive Function Study (SCOPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Health
• Intervention / Treatment: Dietary supplement: Soluble Corn Fiber; Dietary supplement: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois at Urbana-Champaign
      • Contact: Naiman A Khan, PhD, RD; Phone Number: 217-300-2197; Email: nakhan2@illinois.edu
      • Principal Investigator: Naiman A Khan, PhD, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soluble Corn Fiber; 22g Soluble Corn Fiber/day for 4 weeks	Dietary supplement: Soluble Corn Fiber; Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks
Placebo Comparator: Maltodextrin; 22g Maltodextrin/day for 4 weeks	Dietary supplement: Maltodextrin; Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Tate and Lyle Ingredients Americas LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Microbiota; Fiber; Cognition
• Other Study ID Numbers: 21839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No