PRebiotic Intervention for Metabolic and MEntal Health (PRIME)

NCT06216626 | Completed

• 1 other identifier: PRIME
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gut microbiome; inflammation; mental health

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein

  To compare the effect of Myota's prebiotic fibre blend versus standard of care on C-Reactive Protein levels

  Baseline and Week 12

Secondary Outcomes (9)

• Depression, Anxiety and Stress Scale (42-item)

  Baseline and Week 12

• Patient Health Questionnaire (PHQ)

  Baseline and Week 12

• Perceived Stress Scale (PSS)

  Baseline and Week 12

• Generalised Anxiety Disorder (GAD) Scale

  Baseline and Week 12

• Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline and Week 12

Other Outcomes (1)

• Dietary fibre intake

  Baseline and Week 12

Study Arms (2)

Prebiotic fibre

EXPERIMENTAL

The treatment group will consume 10g per day of a diverse prebiotic fibre supplement. Supplements are powdered and unflavoured, and given to the participants in 300g packets lasting for 30 days. A 10g scoop is included in each packet and participants are advised to consume one level scoop at any time of the day. Participants are provided with examples on how to consume the supplement (e.g., breakfast cereal, coffee, tea, water).

Dietary Supplement: myota's prebiotic fibre blend

Control

ACTIVE COMPARATOR

Participants are provided with standard of care (dietary advice). Recommendations for diet and lifestyle advice are provided by a UK-registered GP, and follow the Heart UK's Healthy Eating Guidelines. These recommendations emphasise a Mediterranean diet, rich in fruit, vegetables, and healthy fats (omega-3 fatty acids), while reducing refined sugar, salt, processed foods, and alcohol intake. The Mediterranean diet is considered a gold-standard for participants with MetS and poor mental health.

Dietary Supplement: myota's prebiotic fibre blend

Interventions

myota's prebiotic fibre blend DIETARY_SUPPLEMENT

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

Control; Prebiotic fibre

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-75 years with a diagnosis of Metabolic Syndrome (MetS), yet not receiving treatment for their symptoms
• MetS is diagnosed using the IDF criteria (Alberti, Zimmet \& Shaw, 2006). MetS is defined as having abdominal obesity (waist circumference ≥ 94 cm in men, and ≥ 80 cm in women) plus two or more of the following: raised triglycerides (≥1.7 mmol/L); reduced HDL-C (\< 1.03 mmol/L in men and \< 1.29 mmol/L in women); raised systolic blood pressure (≥ 130 mmHg); raised diastolic blood pressure (≥ 85 mmHg); treatment of previously diagnosed hypertension; raised fasting plasma glucose (≥ 5.6 mmol/L); or previously diagnosed with pre-diabetes.
• Capacity to give informed consent
• Ability to comply with study requirements.

You may not qualify if:

• Includes a current diagnosis of Type 1 or 2 diabetes or cardiovascular disease
• receiving medications that lower cholesterol, blood pressure, or blood glucose levels
• pregnancy, lactation, or an intent to become pregnant during the course of the study
• continuous antibiotic use for \> 3 days within 1 month prior to enrolment
• continuous use of weight-loss drug for \> 1 month before screening
• major change in dietary intake in past month (e.g. excluding whole food groups)
• currently consuming large doses of prebiotic or probiotic supplements
• prior use (\< 6 months) of any blood glucose or cholesterol lowering medication
• a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; weight loss surgery
• irritable bowel disease
• end stage renal disease
• active cancer, or treatment for any cancer, in last 3 years.

Sponsors & Collaborators

• Myota GmbH: lead

Study Sites (1)

Myota Health

London, EC1N 2SW, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome; Anxiety Disorders; Inflammation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Caitlin V Hall, PhD

  myota health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The current protocol is an open-label parallel randomised controlled trial. Participants will be randomised into one of two study arms: a prebiotic fibre intervention arm or control arm (standard of care - Heart UK's Healthy Eating Guidelines). Participants in the fibre intervention arm will consume 10g of a powdered fibre mix daily for 12 weeks. Both groups will not receive any additional nutrition support beyond Heart UK Healthy Eating Guidelines during the intervention. Participants will be instructed to maintain their normal lifestyle and diet, and avoid consuming other probiotic or prebiotic (fibre-based) products during the study.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: June 19, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)