Investigating the potential health benefits of ergothioneine supplementation for people with metabolic syndrome
- Conditions
- Metabolic syndromeNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN25890011
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 108
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 14/05/2021:<br> 1. Recruitment and completion will be measured in the numbers of participants enrolling and completing all study visits<br> 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<br><br> _____<br><br> Previous primary outcome measures:<br> 1. Recruitment and completion will be measured in the numbers of participants enrolling and completing all study visits<br> 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<br>
- Secondary Outcome Measures
Name Time Method