Dietary Fiber, Microbiota and Cognitive Function in Healthy Adults

NCT04951674 | Unknown

• 1 other identifier: APC135
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary fiber is well-known for its many health benefits, including the support of gastrointestinal, metabolic, and mental health. Although studies investigating whole dietary patterns in relation to cognition have demonstrated that diet quality and a healthy dietary pattern are associated with better cognitive performance, the role of dietary fiber in this regard is understudied. In the last decade, the role of the microbiota (trillions of microbes inhabiting the gut) in influencing various aspects of human health, including mental health and behavior, has also become established. Importantly, dietary fiber has been shown to positively affect the microbiota composition. In this study, the role of dietary fiber in cognition through the lens of the microbiota is investigated. A two-part study including an observational (study 1) and interventional (study 2) arm has been designed. In study 1, the observational arm, 150 healthy individuals (30-60 years of age) will be recruited and grouped into high-fiber (\>25 g/day, n=75) and low-fiber (\<18 grams/day, n=75) consumers based on habitual dietary intake. Cognitive tasks (attention, episodic memory, decision making), psychological dimensions including impulsivity and emotional reactivity, biological samples (feces, blood, saliva, urine) and questionnaires about general health will be collected. In study 2, the interventional arm, a subgroup (n=60) of individuals from the low-fiber group will further be randomized into an 8-week randomized-controlled, parallel, single-blinded intervention to either receive a high fiber (n=30, aim 30 grams/day) or control (n=30) diet education. During the intervention period, individuals will provide repeated fecal samples in order to assess temporal microbial changes. At the end of the intervention period, individuals will undergo the same testing regarding cognitive and psychological variables and the same biological samples will be collected. The investigators hypothesize that participants with higher dietary fiber intake at baseline will perform better in the cognitive tasks compared to individuals with low fiber intake, and that this difference can, in part, be mediated by the gut microbiota. Further the investigators hypothesize that through the dietary intervention the microbiota composition will positively shift to include more beneficial microbes and that cognitive performance will improve following the intervention.

Conditions

Healthy

Keywords

Dietary fiber; Microbiota; Cognition; Diet; Microbiota-Gut-Brain Axis

Outcome Measures

Primary Outcomes (4)

• Cognitive performance - Attention

  Assessment of attention using the Paced Auditory Serial Addition Test (PASAT)

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Cognitive performance - Episodic memory

  Assessment of episodic memory using the Modified Rey Auditory Verbal Learning Test (ModRey)

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Cognitive performance - Risky decision making

  Assessment of risky decision making using the Cambridge Gambling Task (CGT)

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Cognitive performance - Affective decision making

  Assessment of affective decision making using the Iowa Gambling Task (IGT).

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

Secondary Outcomes (7)

• Microbiota composition and function

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Blood inflammatory profile

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Salivary cortisol concentrations

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Stress assessment

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

• Anxiety assessment

  Differences between groups at baseline and changes after 8-week of diet intervention in active group

Study Arms (2)

DIET

EXPERIMENTAL

Participants will receive four individual, approximately 30-minute long dietary education sessions. The participants will receive detailed instructions (including meal plans, information on high fiber foods and serving sizes) on how to consume at least 30 grams of fiber per day.

Other: High fiber diet

CONTROL

PLACEBO COMPARATOR

No diet education. Group will spend same amount of time with study dietitian, but discussion is limited to review of current eating habits and minimal input on eating habits with referencing the standard food pyramid.

Other: Control diet

Interventions

High fiber diet OTHER

30 grams of fiber per day

DIET

Control diet OTHER

No diet education and change in diet

CONTROL

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 30 and 60 years of age.
• Be in generally good health as determined by the investigator.

You may not qualify if:

• Are less than 30 and greater than 60 years of age.
• Have a significant acute or chronic coexisting illness \[cardiovascular, gastrointestinal (GI) \[to include functional GI disorders, inflammatory bowel disease, celiac disease, lactose intolerance, food allergies\], immunological, psychiatric \[to include formal or as determined by MINI Psychiatric interview, diagnosis of current major depression, anxiety disorder, bipolar spectrum disorder, schizophrenia, other DSM-IV Axis I disorder\], neurodevelopmental disorders, immunological, metabolic disorders \[to include type I or II diabetes\], or any condition which contraindicates, in the investigators judgement, entry to the study,
• Have a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; all psychoactive medications \[to include anxiolytics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids and opioid pain relievers), laxatives, enemas, antibiotics, anti-coagulants, over-the counter non-steroidal anti-inflammatories (NSAIDS). Participants should have a wash-out period of 4 weeks.
• Current prebiotic or probiotic supplement use (a wash-out period of 4 weeks after cessation will allow entry to the study).
• Females who are peri-menopausal, menopausal or post-menopausal.
• Females who are pregnant or planning a pregnancy, or lactating.
• Participants who are not fluent in English or English is not first language.
• Are color blind.
• Have dyslexia or dyscalculia.
• Are a current habitual daily smoker.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
• Participants receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
• Have a malignant disease or any concomitant end-stage organ disease.
• Have completed a study in the laboratory in the past 4 years.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

APC Microbiome Ireland, University College Cork

Cork, Ireland

RECRUITING

Related Publications (2)

• Berding K, Carbia C, Cryan JF. Going with the grain: Fiber, cognition, and the microbiota-gut-brain-axis. Exp Biol Med (Maywood). 2021 Apr;246(7):796-811. doi: 10.1177/1535370221995785. Epub 2021 Feb 28.

  PMID: 33641478 BACKGROUND

• Cryan JF, O'Riordan KJ, Cowan CSM, Sandhu KV, Bastiaanssen TFS, Boehme M, Codagnone MG, Cussotto S, Fulling C, Golubeva AV, Guzzetta KE, Jaggar M, Long-Smith CM, Lyte JM, Martin JA, Molinero-Perez A, Moloney G, Morelli E, Morillas E, O'Connor R, Cruz-Pereira JS, Peterson VL, Rea K, Ritz NL, Sherwin E, Spichak S, Teichman EM, van de Wouw M, Ventura-Silva AP, Wallace-Fitzsimons SE, Hyland N, Clarke G, Dinan TG. The Microbiota-Gut-Brain Axis. Physiol Rev. 2019 Oct 1;99(4):1877-2013. doi: 10.1152/physrev.00018.2018.

  PMID: 31460832 BACKGROUND

Study Officials

• John F Cryan, PhD

  APC Microbiome Ireland, University College Cork

  PRINCIPAL INVESTIGATOR

• Gerard Clarke, PhD

  APC Microbiome Ireland, University College Cork

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Clarke, PhD

CONTACT

00353214901721; G.Clarke@ucc.ie

Kirsten Berding, PhD

CONTACT

00353214901721; kirsten.berdingharold@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)