NCT05066425

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 4, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

July 27, 2021

Last Update Submit

October 1, 2021

Conditions

Health

Keywords

MicrobiotaCognitionFiber

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Gastrointestinal Microbiota

    4 weeks

  • Fecal Metabolites

    4 weeks

  • Mood/Well-being

    4 weeks

Study Arms (2)

Soluble Corn Fiber

EXPERIMENTAL

22g Soluble Corn Fiber/day for 4 weeks

Dietary Supplement: Soluble Corn Fiber

Maltodextrin

PLACEBO COMPARATOR

22g Maltodextrin/day for 4 weeks

Dietary Supplement: Maltodextrin

Interventions

Soluble Corn FiberDIETARY_SUPPLEMENT

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

Soluble Corn Fiber
MaltodextrinDIETARY_SUPPLEMENT

Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks

Maltodextrin

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • \<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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Interventions

maltodextrin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

October 4, 2021

Study Start

August 2, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

October 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)