Clinical trial NCT06689501: 12-Week Trial Investigating L-carnitine Tartrate, Dihydrocapsiate and Protein Yeast Hydrolysate on Energy Intake and Expenditure in Overweight Adults
Official title: Investigating the Effect of the Combination of L-carnitine Tartrate, Dihydrocapsiate and Protein Yeast Hydrolysate (DNF10) for 12 Weeks on Energy Intake and Energy Expenditure in Overweight and Obese Adults: A Randomised Controlled Trial- (SPICE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Imperial College London
name: Imperial Clinical Trials Unit (ICTU)
First posted: 2024-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria

1. Aged 21-65 years old (inclusive)
2. Male and Female
3. Body Mass Index (BMI) 28 - \<32kg/m2 western criteria for western subjects or 25 - \<30kg/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 exclusion criteria, diet reducing a specific macronutrient, diet significantly reducing calorie intake, excluding a group of food that was not excluded before).
6. Known food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
7. 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)
8. Known congenital dysfunction of specific organic cation carnitine transporter OCTN2
9. Anaemia
10. Women of child-bearing potential with irregular menstrual cycle within the past year of the screening visit.
11. Pregnancy or lactation
12. Chronic metabolic disease (except high cholesterol)
13. History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
14. Life expectancy less than 1 year
15. Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)
16. 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
17. History and ongoing psychiatric illness that affect the primary and secondary outcomes of this trial.
18. Asthma or chronic lung disease requiring long term medications or oxygen.
19. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
20. Cancer, coronary heart disease
21. Subjects with history of hypo- and hyperthyroidism
22. Recent blood donation (\<8 weeks)
23. Drink \>14 units of alcohol per week on a regular basis
24. Consumption of recreational drugs
25. Current smokers (daily)

Primary outcomes:
measure: Change in mean energy intake
timeFrame: week 0 to week 4
Secondary outcomes:
measure: 1. ENERGY EXPENDITURE
timeFrame: At Week 4 and 12
measure: 1. ENERGY EXPENDITURE
timeFrame: At Week 4 and 12
measure: 2. ENERGY INTAKE AND APPETITE
timeFrame: At Week 12
measure: 2. ENERGY INTAKE AND APPETITE
timeFrame: At Week 4 and 12
measure: 2. ENERGY INTAKE AND APPETITE
timeFrame: At Week 4 and 12
measure: 3. ANTHROPOMETRIC MEASURES
timeFrame: At Week 4 and 12
measure: 3. ANTHROPOMETRIC MEASURES
timeFrame: At Week 4 and 12
measure: 3. ANTHROPOMETRIC MEASURES
timeFrame: At Week 4 and 12
measure: 3. ANTHROPOMETRIC MEASURES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 4. SAFETY PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
measure: 5. METABOLIC BLOOD PROFILES
timeFrame: At Week 4 and 12
Other outcomes:
measure: Exploratory Endpoint: METABOLIC BLOOD PROFILES
timeFrame: Week 4 and 12
measure: Exploratory Endpoint: METABOLIC BLOOD PROFILES
timeFrame: Week 4 and 12
measure: Exploratory Endpoint: METABOLIC BLOOD PROFILES
timeFrame: Week 4 and 12
measure: Exploratory Endpoint: METABOLIC BLOOD PROFILES
timeFrame: Week 4 and 12
measure: Exploratory Endpoint: METABOLIC BLOOD PROFILES
timeFrame: Week 4 and 12
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd
Study officials:
affiliation: Imperial College London, Department of Metabolism, Digestion and Reproduction
name: Edward Chambers
role: PRINCIPAL_INVESTIGATOR
References: