Overweight and Obesity
Conditions
Brief summary
This is a single-centre, double-blind, randomised, placebo-controlled, 2-arm, parallel-design trial. This trial will examine the impact of a combined treatment of L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate (otherwise known as the study product) over 12 weeks on energy intake and expenditure in overweight and obese adults. Approximately 44 participants will be recruited to this trial. Participants will give consent to investigator sites to collect their data. The participants will either be randomised to take the study product or placebo. The main question that this trial aims to answer is: The effect of the study product (L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate) as compared to placebo on mean energy intake via 3 x 24h dietary recalls online at week 4.
Detailed description
Obesity is a global public health issue that is linked with multiple diseases affecting the body such as the heart, lungs, digestion and metabolism. There are many factors to weight gain that can lead to overweight or obesity. One of them is when more calories (energy for the body from food and drink) are taken in than being used. Weight re-gain of 30-50% of the weight loss occurs within 1 year and 50% of the patients will return to their baseline weight 5 years after they started their weight loss regime. Weight re-gain after weight loss remains an unmet medical need. This is a single-centre, double-blind, placebo-controlled, 2-arm, 12-week trial with randomisation to either the study product or placebo. The study product is blend of ingredients composed of L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate (DNF-10®). Participants will consume a total of 4 capsules a day during 2 different intake occasions. The matching placebo is microcrystalline cellulose. Ingredients within the study product have individually shown to increase energy expenditure, decrease energy intake, decrease body weight and/or fat mass and decrease appetite in humans, via different pathways. However, they have never been studied in combination. With the combination of these ingredients, Investigator hypothesises the increase of the size effect on negative energy balance via decreasing appetite/energy intake and increasing energy expenditure, targeting different pathways, to \>100 kcal/day. Study participants will provide written informed consent prior to any trial procedures taking place. Participants will attend clinic at the study site 4 times in total as well as complete a validated online questionnaire called Intake24 about foods they've eaten between the in-person study visits. Main trial procedures include, blood sample collection, online 3x24h dietary recall completion, subjective appetite feelings via 100mm visual analogue scale (VAS) for hunger, fullness, satiety and desire to eat, ad libitum energy intake, energy expenditure (including fat oxidation) using indirect calorimetry, anthropometric measures and administration/compliance to treatment.
Interventions
COMBINATION_PRODUCTSPICE BLEND CAPSULE
The study product is a powder mix of L-carnitine tartrate yeast protein hydrolysate and dihydrocapsiate.in the format of hard vegetable green capsules. Participants will consume a total of 4 capsules a day split in two servings.
OTHERPlacebo
The matching placebo is microcrystalline cellulose in the format of hard vegetable green capsules. Participants will consume a total of 4 capsules a day split in two servings.
Sponsors
Imperial College London
Imperial Clinical Trials Unit (ICTU)
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
A single-centre, double-blind, placebo-controlled, 2-arm, 12-week trial with randomisation to either the study product (blend of ingredients composed of L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate) or placebo.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 21-65 years old (inclusive) 2. Male and Female 3. Body Mass Index (BMI) 28 - \<35kg/m2 western criteria for western subjects or 25 - \<32kg/m2 for south-Asian ethnicities 4. Comfortable using technology, such as a smartphone or laptop 5. Written informed consent
Exclusion criteria
1. 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) 2. Weight change of ≥3 kg in the preceding 6 months 3. Eating behaviour disorders such as emotional, restrained or external eating determined via Dutch Eating Behaviour Questionnaire (DEBQ). 4. 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) 5. Significant restrictions on food intake (i.e., regular breakfast skipping, regular cut on carbohydrates, regular intermitted fasting, increased alcohol consumption beyond units defined in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean energy intake | week 0 to week 4 | Change in mean energy intake as measured via three consecutive 24-hour dietary recalls conducted online via Intake24, from week 0 to week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. ENERGY EXPENDITURE | At Week 4 and 12 | a) Postprandial (following a mixed meal tolerance test via standard breakfast) energy expenditure and substrate oxidation (respiratory quotient, fat and carbohydrate oxidation) at 40 - 60min, 100 - 120mins, 160 - 180 min relative to standard breakfast intake (SP will be taken 30 min before breakfast intake) using indirect calorimetry at week 4 and week 12. Indirect calorimetry is a gold-standard, non-invasive technique which is clinically recommended that calculates energy expenditure and substrate oxidation by measuring pulmonary gas exchange (i.e. their production of carbon dioxide and the oxygen inspired). This allows to calculate rates of energy expenditure and substrate oxidation. Endpoint will be incremental Area Under the Curve (iAUC) at 3h. |
| 2. ENERGY INTAKE AND APPETITE | At Week 12 | a) Energy intake: via 3 x 24h dietary recall (Intake24h). |
| 4. SAFETY PROFILES | At Week 4 and 12 | a) Gastrointestinal side effects: For the endpoint, measured using 100mm scale. |
| 5. METABOLIC BLOOD PROFILES | At Week 4 and 12 | c) Fasting: HbA1c. Units of measurement: mmol/mol |
| 3. ANTHROPOMETRIC MEASURES | At Week 4 and 12 | a) Body weight: At week 4 and 12. Units of measurement: Kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoint: METABOLIC BLOOD PROFILES | Week 4 and 12 | Postprandial: Gut hormones: Glucose-dependent insulinotropic polypeptide \[GIP\], Cholecystokinin, Oxyntomodulin) at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement: pM |
Countries
United Kingdom
Outcome results
None listed