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PRebiotic Intervention for Metabolic and MEntal Health (PRIME)

NCT06216626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-23

No results posted yet for this study

Summary

The purpose of the study is to determine whether a daily prebiotic fibre blend can reduce systemic inflammation, dyslipidemia, and self-report measures of mental health in individuals with metabolic syndrome. This study will help shape a larger randomised controlled study (RCT) powered to assess efficacy in a bigger cohort of patients.

Primary outcome measures will explore the efficacy of a prebiotic fibre blend on systemic inflammation. Secondary and exploratory outcomes measures will explore the efficacy of the prebiotic blend on clinical biomarkers associated with cardiometabolic risk factors, microbiota features, and mental health. Using these data, we will also estimate in-year savings for the NHS in the metabolic syndrome population on a per participant basis.

Conditions

  • Metabolic Syndrome
  • Anxiety
  • Mood
  • Stress

Interventions

DIETARY_SUPPLEMENT

myota's prebiotic fibre blend

Each 10g daily serve of supplement contains the following fibres: * Fructooligosaccharides * Inulin * Resistant dextrin * Resistant maltodextrin * Partially hydrolysed guar gum * Guar gum

Sponsors & Collaborators

  • Myota GmbH

    lead INDUSTRY

Principal Investigators

  • Caitlin V Hall, PhD · myota health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216626 on ClinicalTrials.gov