The Effects of Prebiotics on Cognitive Functioning and Weight Gain in Psychosis

NCT03153046 | Completed

• 1 other identifier: 12302
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month. There is evidence suggesting the immune system is linked to brain function and weight gain, both parameters that has been implicated in psychosis and antipsychotic use, and may underlie some schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal microbiota has been shown to modulate the immune system and reduce the inflammatory response in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary changes, the growth of beneficial gut bacteria can be enhanced using a natural food supplement similar to GOS known as prebiotics. The study will be controlled by taking maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar compounds. The study will involve asking patients to take dietary supplement for a total of 24 weeks; GOS for 12 weeks and maltodextrin for 12 weeks as a control. Participants will be randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving GOS followed by maltodextrin. Participants will be assessed on cognitive function and weight gain at 3 specified time points.

Conditions

Schizophrenia

Keywords

prebiotics; cognitive impairment; weight gain

Outcome Measures

Primary Outcomes (1)

• Cognitive Assessments using the BAC's Test

  The Brief Assessment of Cognition (BAC), developed by NeuroCog. Trials, assesses five different domains of cognitive function with six tests (i.e., Verbal Memory \& Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London)). Outcome measures from each test will be combined into one composite Z-Score, and transformed into a T-Score to evaluate global cognition on a standardise curve.

  1 year

Secondary Outcomes (3)

• Body Mass Index (BMI)

  1 year

• Waist-Hip Ratio

  1 year

• Circulating Inflammatory Markers

  1 year

Study Arms (2)

Prebiotics

EXPERIMENTAL

12 week ingestion of prebiotics, Bimuno galacto-oligosaccharide (B-GOS).

Dietary Supplement: prebiotics

Maltodextrin

PLACEBO COMPARATOR

12 week ingestion of maltodextrin

Dietary Supplement: Maltodextrin

Interventions

prebiotics DIETARY_SUPPLEMENT

Bimuno (BGOS): The active supplement of the food supplement (Bimuno) used in this study is called galacto-oliogosaccharides (Bimuno®, BGOS). BGOS is a compound metabolised by specific bifidobacteria, which are beneficial bacteria, in our colon. Bimuno (2.3 calories) is composed by the following ingredients per gram of Bimuno: 0.96g dry matter; \<01g Fat; \<0.06g Protein; 0.821g GOS; 0.119g Lactose; 0.0331g Glucose and 0.0029g Galactose. Bimuno is tasteless. Bimuno will be supplied in coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.

Also known as: Bimuno® galacto-oliogosaccharides (BGOS)

Prebiotics

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin is a polysaccharide in powder form, which grows most bacteria in the gut, and not specifically the beneficial bifidobacteria. The placebo will also be provided in daily coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink. This placebo has been used in previous studies, in which Bimuno was used as the active intervention. The placebo will be similar in taste and colour to the active intervention.

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female, aged 18-60 years of age.
• Participant is willing and able to give informed consent for participation in the study
• Diagnosed with psychotic disorder ICD-10 (e.g., schizophrenia, schizoaffective disorder, psychosis NOS)
• Stable on psychotropic medication for \>1 month with cognitive deficits (Cognitive deficits will be evaluated using the BACS test cut off score of 1.0 standard deviation below the healthy mean; those that score within the normal range i.e., within 1.0 standard deviations of the mean are not considered cognitively impaired and thus will not be included in the study)

You may not qualify if:

• Not considered suitable for the study by the clinical team, for whatever reason
• Current inpatient in psychiatric hospital
• Additional major medical disorders (including diseases affecting the human gastrointestinal tract and blood-borne disorders)
• Antibiotic, probiotic and/or prebiotic treatment in at least the 3 previous months
• Participants who are taking any other food supplements which, in the opinion of the Investigators, may affect the results
• Participants who have a known intolerance to lactose (self-identified)
• Any significant recent change in diet which, to the discretion of the Investigators, may affect the results

Sponsors & Collaborators

• University of Oxford: lead
• Clasado Biosciences Ltd: collaborator

Study Sites (1)

Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (1)

• Kao AC, Safarikova J, Marquardt T, Mullins B, Lennox BR, Burnet PWJ. Pro-cognitive effect of a prebiotic in psychosis: A double blind placebo controlled cross-over study. Schizophr Res. 2019 Jun;208:460-461. doi: 10.1016/j.schres.2019.03.003. Epub 2019 Mar 12. No abstract available.

  PMID: 30876680 RESULT

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction; Weight Gain

Interventions

Prebiotics; maltodextrin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Belinda Lennox, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding of compounds will be provided by Clasado Ltd., the company supplying the prebiotics and maltodextrin.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 24 week cross-over at 12 week involving preiotics and maltodextrin

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 15, 2017
• Study Start: May 8, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 18, 2019

Record last verified: 2018-05

Locations

GB (1)