12-Week Trial Investigating L-carnitine Tartrate, Dihydrocapsiate and Protein Yeast Hydrolysate on Energy Intake and Expenditure in Overweight Adults

Korábbi kezelés

• On unstable medication in the last 6 months, that may impact trial outcomes (e.g., including antibiotics, steroids or medication affecting thyroid hormones, and gut hormones)
• Taking any drugs in the past 3 months that are GLP-1 receptor analogues, SGLT-2 inhibitors, any weight loss medications and any of the following drugs: cephaloridine, verapamil, valproic acid, and sulfonylureas, usually acting by competitive inhibition of L-carnitine transport by OCTN2 or drugs that affect outcome of interest, including showing a defect on fat absorption (e.g., Orlistat)
• Consumption of recreational drugs

Más betegség

• Eating behaviour disorders such as emotional, restrained or external eating determined via Dutch Eating Behaviour Questionnaire (DEBQ).
• Known food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
• Chronic metabolic disease (except high cholesterol)
• History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
• Gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc.) or disorders such as Chron's disease or inflammatory bowel syndrome or disorder
• History and ongoing psychiatric illness that affect the primary and secondary outcomes of this trial.
• Asthma or chronic lung disease requiring long term medications or oxygen.
• Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
• Cancer, coronary heart disease
• Subjects with history of hypo- and hyperthyroidism
• Medical history of difficulties in tolerating/undergoing study procedures planned in the present study, (e.g., like cannulation)

Laborértékek

• Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)

Egyéb

• Weight change of ≥3 kg in the preceding 6 months
• On a weight loss regime (defined by actively following a diet such as Atkins, weight watchers, meal replacements, low or very low carbohydrate diet, ketogenic diet, intermediate fasting or enrolled into a governmental health program)
• Significant restrictions on food intake (i.e., regular breakfast skipping, regular cut on carbohydrates, regular intermitted fasting, increased alcohol consumption beyond units defined in exclusion criteria, diet reducing a specific macronutrient, diet significantly reducing calorie intake, excluding a group of food that was not excluded before).
• Known congenital dysfunction of specific organic cation carnitine transporter OCTN2
• Anaemia
• Pregnancy or lactation
• Life expectancy less than 1 year
• Recent blood donation (<8 weeks)
• Drink >14 units of alcohol per week on a regular basis
• Current smokers (daily)

• Aged 21-65 years old (inclusive)
• Male and Female
• Body Mass Index (BMI) 28 - <35kg/m2 western criteria for western subjects or 25 - <32kg/m2 for south-Asian ethnicities
• Comfortable using technology, such as a smartphone or laptop
• Written informed consent