Prevention of metabolic disease in currently healthy volunteers Nutritional, Metabolic, Endocrine
Conditions
Interventions
This pilot study will be a randomised-controlled cross-over study recruiting 10 healthy participants consisting of three visits that will take place over a period of a maximum of 2 months.
The order
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Body mass index (BMI) of 18.5-29.9 kg/m2 2. Individuals aged between 18-65 years (inclusive)
Exclusion criteria
Exclusion criteria: 1. Weight change of >3 kg in last 3 months 2. HbA1c exceeding 41 mmol/mol (8.5%) 3. Bowel reconstruction surgery 4. Vegan or vegetarians 5. Food allergies or intolerances 6. Blood donation in the last 3 months 7. Current smokers 8. Substance abuse 9. Excess alcohol intake (>14 units per week) 10. Pregnancy or breastfeeding 11. Cardiovascular disease 12. Cancer 13. Kidney failure 14. Participation in another research study in the past 12 weeks 15. Diagnosed gastrointestinal conditions 16. Use of antibiotics in the past 3 months 17. Use of anti-inflammatory drugs or steroids or thyroid hormones 18. New medication in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose and triglyceride incremental area under the curve (iAUC) measured using blood samples at 12 timepoints (-15, -10, 15, 30, 60, 120, 180, 195, 210, 240, 300, 360) throughout the three study visits | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight measured by bioelectrical impedance scale at each of the three study visits 2. Body composition (fat mass, lean mass) measured by bioelectrical impedance scale at each of the three study visits 3. Blood pressure measured using a blood pressure cuff at each of the three study visits 4. Insulin, free fatty acids and circulating amino acids measured in the blood at 12 timepoints (-15, -10, 15, 30, 60, 120, 180, 195, 210, 240, 300, 360) throughout the three study visits 5. Breath hydrogen measured using a Gastrolyzer machine at 12 timepoints (-15, -10, 15, 30, 60, 120, 180, 195, 210, 240, 300, 360) throughout the three study visits 6. Appetite measured using visual analogue scales at 12 timepoints (-15, -10, 15, 30, 60, 120, 180, 195, 210, 240, 300, 360) throughout the three study visits 7. Energy intake measured using an ad-libitum meal at the end of each of the three study visits 8. Stool microbiota composition measured in the stool samples provided at the beginning of each of the three study visits 9. Metabolite concentrations measured in the urine and serum samples collected at each of the three study visits | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Pugh
Outcome results
None listed