Status:
COMPLETED
PRebiotic Intervention for Metabolic and MEntal Health (PRIME)
Lead Sponsor:
Myota GmbH
Conditions:
Metabolic Syndrome
Anxiety
Eligibility:
All Genders
18-75 years
Phase:
NA
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 s...
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 esti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06216626
Start Date
June 19 2023
End Date
December 22 2023
Last Update
July 23 2024
Active Locations (1)
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1
Myota Health
London, United Kingdom, EC1N 2SW