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Fibre and Mental Wellbeing Feasibility Trial

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University of Reading

Status

Active, not recruiting

Conditions

Affect (Mental Function)
Anxiety
Sleep
Stress

Treatments

Other: Fibre arm

Study type

Interventional

Funder types

Other

Identifiers

NCT06899607
2025-037-PH

Details and patient eligibility

About

This feasibility study will explore whether adding an extra 10 grams of fibre to participants' daily diet for two weeks would improve their mental health and wellbeing.

Full description

The current pre-post single-arm feasibility trial will investigate whether increasing daily fibre intake by 10 grams for two weeks enhance depression, anxiety, stress, sleep quality, gut health, and optimism in 18-40 year-old young adults. Participants will be provided a list of high fibre food items. Outcome measures will be acquired before and after 2-weeks . These will include cognitive measures of measures of depression, anxiety, and stress symptomatology; sleep; gastrointestinal symptomatology; optimism.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aging between 18-40 years old
  • Having normal vision and hearing
  • Having a body mass index between 18.5 and 30
  • Not following a high fibre diet >20g fibre/day as assessed by using the FiberScreen

Exclusion criteria

  • Smoking
  • Having food allergies
  • Following restrictive and/or unbalanced diets
  • Changing dietary intake majorly in past month
  • Being diagnosed with any psychiatric or neurologic conditions
  • Being diagnosed with any cardiometabolic diseases, or hypertension or thrombosis related disorders or suffer from thyroid disease
  • Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
  • Currently consuming prebiotic or probiotic supplements or laxatives
  • Continuous antibiotic use for > 3 days within 1 month prior to enrolment
  • Continuous use of weight-loss drug for > 1 month before screening
  • Having a significant gastrointestinal (GI) condition

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Fibre arm
Experimental group
Treatment:
Other: Fibre arm

Trial contacts and locations

1

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Central trial contact

Piril Hepsomali, PhD

Data sourced from clinicaltrials.gov

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