Metabolic syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
Consenting participants will be randomised in a double-blind fashion to one of three groups to receive either placebo (0 mg ergothioneine), 5 mg ergothioneine, or 30 mg ergothioneine for consumption a
aiming to recruit 108 participants for n=36 in each group. The randomisation schedule will be carried out by a collaborator who will not be involved in any other part of this trial and who will also b
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must be 18-70 years old, overweight or obese, and have risks of metabolic syndrome, defined by presenting with at least two of the six following criteria: 1. BMI >25 kg/m² 2. Abdominal obesity: high waist circumference (Asian/Asian British - men =90 cm; women =80 cm; White and all other ethnic groups - men =94 cm, women =80 cm) 3. Fasting glucose =100 mg/dl (5.6 mmol/l) or treatment for elevated blood glucose 4. Blood pressure =130/85 mmHg or treatment for elevated blood pressure 5. Triglycerides =150 mg/dl (1.7 mmol/l) or treatment for elevated triglycerides 6. Cholesterol-high density lipoprotein (HDL-C) < 40 mg/dl (1.0 mmol/l) for male or < 50 mg/dl (1.3 mmol/l) for female or treatment for low HDL-C
Exclusion criteria
Exclusion criteria: 1. Participants who are under 18 years old or over 70 years 2. Women who are pregnant or lactating 3. Participants who smoke 4. Participants who consume =28 units of alcohol per week (28 units = ~10 medium glasses of wine (175 mL) or ~10 pints of beer/cider) 5. Participants who have taken dietary/antioxidant supplements within the last 4 months (adequate washout period) 6. Participants who have newly implemented a diet or exercise regime (=150 min/week moderate aerobic exercise or =75 min/week vigorous aerobic exercise) aimed at weight loss 7. Participants who have gained or lost weight of >3 kg or more in last month 8. Participants who are following lifestyle change advice 9. Diagnosis of liver disease, diabetes, heart disease, kidney disease or intestinal disorders (Crohn’s disease, short bowel syndrome, pancreatic insufficiency, cystic fibrosis, tropical sprue, Whipple's disease, chronic pancreatitis, gastrojejunostomy, surgical treatment for obesity, cholestasis, biliary atresia, parasitic infections) 10. Diagnosis of cancer or end of cancer treatment within 2 years 11. Participants taking prescription anti-inflammatory medicines (occasional aspirin, paracetamol, ibuprofen use acceptable) 12. Participants who have been diagnosed with a blood borne disease (HepB, HIV etc.) 13. Participants receiving antibiotic treatment within last month or 3 courses within the last 6 months 14. Participating in other clinical trials that may influence outcomes 15. Participants who are impaired in cognition or cannot complete the trial independently 16. Participants who have difficulties in understanding written and/or verbal English 17. Participants who cannot come to the University 18. Participants who are unwilling or unable to provide informed consent 19. Participants who can not wear a face mask during the visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 14/05/2021: 1. Recruitment and completion will be measured in the numbers of participants enrolling and completing all study visits 2. Supplementation compliance will be measured both by capsule counting (participants returning packaging and untaken supplements) and the measurement of ergothioneine in serum by LC-MS at baseline, 6 weeks and 12 weeks _____ Previous primary outcome measures: 1. Recruitment and completion will be measured in the numbers of participants enrolling and completing all study visits 2. Supplementation compliance will be measured both by capsule counting (participants returning packaging and untaken supplements) and the measurement of ergothioneine in plasma by HPLC at baseline, 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/08/2021: 1. Levels of malondialdehyde (MDA), as a primary serum marker of oxidative stress (specifically, lipid peroxidation), will be measured by high-performance liquid chromatography (HPLC) at baseline, 6 weeks, and 12 weeks 2. Serum levels of tumour necrosis factor-alpha (TNF-a), as a marker of inflammation, will be measured by enzyme-linked immunosorbent assay (ELISA) at baseline, 6 weeks, and 12 weeks 3. Serum levels of nuclear factor erythroid 2-related factor 2 (Nrf2), as a marker of inflammation, will be measured by enzyme-linked immunosorbent assay (ELISA) at baseline, 6 weeks, and 12 weeks 4. C-reactive protein (CRP) will be measured in whole blood using a rapid point-of-care multi-assay blood analyser at baseline, 6 weeks and 12 weeks 5. NADPH oxidase 4 (NOX4) expression will be measured by real-time quantitative polymerase chain reaction (qPCR) at baseline, 6 weeks, and 12 weeks 6. Serum alanine transaminase (ALT), as a marker of liver function, will be measured by commercial assay kit at baseline, 6 weeks, and 12 weeks. 7. Height will be measured by stadiometer at baseline 8. Body weight will be measured by beam scale at baseline, 6 weeks and 12 weeks 9. Blood pressure will be measured by blood pressure monitor at baseline, 6 weeks and 12 weeks 10. Waist circumference will be measured by tape at baseline, 6 weeks and 12 weeks 11. Triglycerides (TAG) will be measured in whole blood using a rapid point-of-care multi-assay blood analyser at baseline, 6 weeks and 12 weeks 13. Cholesterol-high density lipoprotein (HDL) will be measured in whole blood using a rapid point-of-care multi-assay blood analyser at baseline, 6 weeks and 12 weeks. 14. Fasting glucose will be measured in whole blood using a rapid point | — |
Countries
England, United Kingdom
Contacts
Public ContactXiaoying Tian
Outcome results
None listed