Phase
Condition
Obesity
Hypertriglyceridemia
Treatment
Placebo
SPICE BLEND CAPSULE
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
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
Exclusion Criteria
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)
Weight change of ≥3 kg in the preceding 6 months
Eating behaviour disorders such as emotional, restrained or external eating determined via Dutch Eating Behaviour Questionnaire (DEBQ).
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 food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
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)
Known congenital dysfunction of specific organic cation carnitine transporter OCTN2
Anaemia
Pregnancy or lactation
Chronic metabolic disease (except high cholesterol)
History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
Life expectancy less than 1 year
Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)
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
Recent blood donation (<8 weeks)
Drink >14 units of alcohol per week on a regular basis
Consumption of recreational drugs
Current smokers (daily)
Medical history of difficulties in tolerating/undergoing study procedures planned in the present study, (e.g., like cannulation)
Study Design
Study Description
Connect with a study center
Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd
London, W12 0HS
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.