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

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.

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.