Metabolic SyndromePRIMENCT06216626
PRebiotic Intervention for Metabolic and MEntal Health (PRIME)
A study testing myota's prebiotic fibre blend in people with Metabolic Syndrome and Anxiety, run by Myota GmbH at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Anxiety, Mood
- What is being tested?
- myota's prebiotic fibre blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects of a Daily Prebiotic Fibre Blend on Inflammation, the Gut Microbiome, and Self-Report Measures of Mental Health in Individuals With Metabolic Syndrome
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.
Read the detailed description
Metabolic syndrome is not a chronic disease, but a cluster of metabolic abnormalities including central obesity, insulin resistance, hyperglycemia, hypertension, and dyslipidemia. In the UK, it's estimated that 1 in 3 adults aged 50 years or over meets the criteria of metabolic syndrome. Emerging evidence suggests that metabolic syndrome is associated with low-grade systemic inflammation, which is thought to play a critical role in the subsequent pathogenesis of various metabolic and cardiovascular diseases. In fact, the inflammatory biomarker, high-sensitivity (hs)-CRP, has been shown to be predictive of whether metabolic syndrome progresses to a chronic disease, including cardiovascular disease (CVD), type 2 diabetes (T2D), and cancer mortality. Alongside metabolic disturbances, recent studies have shown that repeated (or long-term) exposure to systemic inflammation is also associated with an increased risk of future depressive and anxiety symptoms, potentially acting via the blood-brain barrier (BBB) interface.
From both a physical and mental health standpoint, it's clear that novel interventions, beyond pharmacotherapy, are needed to reverse the progression of metabolic syndrome, and reduce the risk of developing a long-term chronic disease, and poor mental health.
It is well established that dietary fibre plays a critical role in reducing symptoms of metabolic syndrome, including improvements in insulin sensitivity, glucose metabolism, lipid profile, and blood pressure. Specifically, dietary fibre has been shown to reduce cholesterol levels by binding to bile acids and promoting their excretion, as well as by decreasing the absorption of dietary cholesterol. Additionally, dietary fibre can slow the absorption of carbohydrates and reduce post-prandial glucose spikes, which may contribute to improvements in insulin sensitivity and metabolic health.
Growing evidence also suggests that the mechanisms underlying the benefits of fibre are thought to be mediated, at least in part, by the gut microbiota and their metabolites, such as short-chain fatty acids (SCFAs). A recent systematic review and meta-analysis of 10 randomised controlled trials found that increased intake of dietary fibre was associated with significant improvements in fasting glucose, insulin resistance, total cholesterol, and low-density lipoprotein (LDL) cholesterol levels in individuals with type 2 diabetes. Furthermore, a randomised controlled trial in individuals with metabolic syndrome found that supplementation with a prebiotic fibre blend led to significant reductions in fasting glucose, insulin resistance, and inflammatory markers. Therefore, increasing prebiotic fibre intake may represent a promising strategy for the prevention and management of metabolic symptoms, but remains poorly understood.
Prebiotics are specific types of fibres found in foods like onion, garlic, artichokes, asparagus, leeks, and chicory root. However, to reap the benefits of prebiotics for given health indications, this requires someone to consume roughly 5-10 onions a day. Prebiotic fibre blends (in powder form) are derived from a diversity of plant-based sources, and allows for the study of prebiotic-based benefits in a feasible, easy, measurable, and controlled way.
In this current study, we aim to assess the effects of a daily prebiotic fibre blend on systemic inflammation, the gut microbiome, lipid profiles, and self-report measures of mental health in individuals with metabolic syndrome. The study will be conducted over 12 weeks, and the findings may provide new insights into the potential role of prebiotics in the prevention and management of physical and mental health risk factors associated with chronic disease.
The study population will include adults aged 18-75 years who meet the criteria for metabolic syndrome. To promote the inclusion and diversity of participants across England, this study will be conducted remotely, by posting participants the at-home collection kits (stool and finger prick tests) and online surveys. This gives access to participants who would otherwise not be able to take part in research.
- Conditions
- Metabolic Syndrome, Anxiety, Mood, Stress
- Being tested
- myota's prebiotic fibre blend
- Keywords
- gut microbiome, inflammation, mental health
- Medical subject headings
- Metabolic Syndrome, Anxiety Disorders, Inflammation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myota's prebiotic fibre blendDietary supplement
Each 10g daily serve of supplement contains the following fibres:
- Fructooligosaccharides
- Inulin
- Resistant dextrin
- Resistant maltodextrin
- Partially hydrolysed guar gum
- Guar gum
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: myota's prebiotic fibre blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive Protein
To compare the effect of Myota's prebiotic fibre blend versus standard of care on C-Reactive Protein levels
Measured: Baseline and Week 12
Secondary outcomes (9)
Depression, Anxiety and Stress Scale (42-item)
To compare the effect of Myota's prebiotic fibre blend versus standard of care on Depression, Anxiety and Stress Scale (42-item) scores. Minimum score = 0, maximum score = 126, where higher scores indicate worse outcomes.
Measured: Baseline and Week 12
Patient Health Questionnaire (PHQ)
To compare the effect of Myota's prebiotic fibre blend versus standard of care on Patient Health Questionnaire scores. Minimum score = 1, maximum score = 27, where higher scores indicate worse outcomes.
Measured: Baseline and Week 12
Perceived Stress Scale (PSS)
To compare the effect of Myota's prebiotic fibre blend versus standard of care on Perceived Stress Scale scores. Minimum score = 0, maximum score = 40, where higher scores indicate worse outcomes.
Measured: Baseline and Week 12
Generalised Anxiety Disorder (GAD) Scale
To compare the effect of Myota's prebiotic fibre blend versus standard of care on Generalised Anxiety Disorder Scale scores. Minimum score = 0, maximum score = 21, where higher scores indicate worse outcomes.
Measured: Baseline and Week 12
Gastrointestinal Symptom Rating Scale (GSRS)
To compare the effect of Myota's prebiotic fibre blend versus standard of care on Gastrointestinal Symptom Rating Scale scores. Scores are calculated for 5 sub-categories: reflux, pain, constipation, diarrhoea, indigestion, where the minimum score is 1 and maximum score is 21, where higher scores indicate worse outcomes.
Measured: Baseline and Week 12
Gut Microbiome Profiles
To compare the effect of Myota's prebiotic fibre blend versus standard of care on gut microbiome profiles
Measured: Baseline and Week 12
Lipid Profiles
To compare the effect of Myota's prebiotic fibre blend versus standard of care on lipid profiles
Measured: Baseline and Week 12
Diastolic blood pressure
To compare the effect of Myota's prebiotic fibre blend versus standard of care on diastolic blood pressure.
Measured: Baseline and Week 12
Systolic Blood pressure
To compare the effect of Myota's prebiotic fibre blend versus standard of care on systolic blood pressure.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 Jun 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myota GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caitlin V Hall, PhD, Principal investigator, myota health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216626
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participants data may be available to other researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Daily Prebiotic Fibre Blend on Inflammation, the Gut Microbiome, and Self-Report Measures of Mental Health in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06216626
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Metabolic Syndrome, Anxiety, Mood, Stress
- Keywords
- gut microbiome, inflammation, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Myota GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metabolic syndrome is not a chronic disease, but a cluster of metabolic abnormalities including central obesity, insulin resistance, hyperglycemia, hypertension, and dyslipidemia. In the UK, it's estimated that 1 in 3 adults aged 50 years or over meets the criteria of metabolic syndrome. Emerging evidence suggests that metabolic syndrome is associated with low-grade systemic inflammation, which is thought to play a critical role in the subsequent pathogenesis of various metabolic and cardiovascular diseases. In fact, the inflammatory biomarker, high-sensitivity (hs)-CRP, has been shown to be predictive of whether metabolic syndrome progresses to a chronic disease, including cardiovascular disease (CVD), type 2 diabetes (T2D), and cancer mortality. Alongside metabolic disturbances, recent studies have shown that repeated (or long-term) exposure to systemic inflammation is also associated with an increased risk of future depressive and anxiety symptoms, potentially acting via the blood-brain barrier (BBB) interface.
From both a physical and mental health standpoint, it's clear that novel interventions, beyond pharmacotherapy, are needed to reverse the progression of metabolic syndrome, and reduce the risk of developing a long-term chronic disease, and poor mental health.
It is well established that dietary fibre plays a critical role in reducing symptoms of metabolic syndrome, including improvements in insulin sensitivity, glucose metabolism, lipid profile, and blood pressure. Specifically, dietary fibre has been shown to reduce cholesterol levels by binding to bile acids and promoting their excretion, as well as by decreasing the absorption of dietary cholesterol. Additionally, dietary fibre can slow the absorption of carbohydrates and reduce post-prandial glucose spikes, which may contribute to improvements in insulin sensitivity and metabolic health.
Growing evidence also suggests that the mechanisms underlying the benefits of fibre are thought to be mediated, at least in part, by the gut microbiota and their metabolites, such as short-chain fatty acids (SCFAs). A recent systematic review and meta-analysis of 10 randomised controlled trials found that increased intake of dietary fibre was associated with significant improvements in fasting glucose, insulin resistance, total cholesterol, and low-density lipoprotein (LDL) cholesterol levels in individuals with type 2 diabetes. Furthermore, a randomised controlled trial in individuals with metabolic syndrome found that supplementation with a prebiotic fibre blend led to significant reductions in fasting glucose, insulin resistance, and inflammatory markers. Therefore, increasing prebiotic fibre intake may represent a promising strategy for the prevention and management of metabolic symptoms, but remains poorly understood.
Prebiotics are specific types of fibres found in foods like onion, garlic, artichokes, asparagus, leeks, and chicory root. However, to reap the benefits of prebiotics for given health indications, this requires someone to consume roughly 5-10 onions a day. Prebiotic fibre blends (in powder form) are derived from a diversity of plant-based sources, and allows for the study of prebiotic-based benefits in a feasible, easy, measurable, and controlled way.
In this current study, we aim to assess the effects of a daily prebiotic fibre blend on systemic inflammation, the gut microbiome, lipid profiles, and self-report measures of mental health in individuals with metabolic syndrome. The study will be conducted over 12 weeks, and the findings may provide new insights into the potential role of prebiotics in the prevention and management of physical and mental health risk factors associated with chronic disease.
The study population will include adults aged 18-75 years who meet the criteria for metabolic syndrome. To promote the inclusion and diversity of participants across England, this study will be conducted remotely, by posting participants the at-home collection kits (stool and finger prick tests) and online surveys. This gives access to participants who would otherwise not be able to take part in research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic fibre | Experimental | Dietary Supplement: myota's prebiotic fibre blendThe 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). |
| Control | Active comparator | Dietary Supplement: myota's prebiotic fibre blendParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myota's prebiotic fibre blendEach 10g daily serve of supplement contains the following fibres: * Fructooligosaccharides * Inulin * Resistant dextrin * Resistant maltodextrin * Partially hydrolysed guar gum * Guar gum | Dietary supplement | Control, Prebiotic fibre |
Primary outcome
C-Reactive Protein
Time frame: Baseline and Week 12
To compare the effect of Myota's prebiotic fibre blend versus standard of care on C-Reactive Protein levels
9 secondary outcomes
Depression, Anxiety and Stress Scale (42-item)
Time frame: Baseline and Week 12
Patient Health Questionnaire (PHQ)
Time frame: Baseline and Week 12
Perceived Stress Scale (PSS)
Time frame: Baseline and Week 12
Generalised Anxiety Disorder (GAD) Scale
Time frame: Baseline and Week 12
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline and Week 12
Gut Microbiome Profiles
Time frame: Baseline and Week 12
Lipid Profiles
Time frame: Baseline and Week 12
Diastolic blood pressure
Time frame: Baseline and Week 12
Systolic Blood pressure
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No. De-identified participants data may be available to other researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin V Hall, PhD principal investigator
myota health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myota's prebiotic fibre blend in people with Metabolic Syndrome and Anxiety, run by Myota GmbH at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-Reactive Protein (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.