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

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)

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Combination product: SPICE BLEND CAPSULE; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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. Pregnancy or lactation
11. Chronic metabolic disease (except high cholesterol)
12. History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
13. Life expectancy less than 1 year
14. Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)
15. 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
16. History and ongoing psychiatric illness that affect the primary and secondary outcomes of this trial.
17. Asthma or chronic lung disease requiring long term medications or oxygen.
18. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
19. Cancer, coronary heart disease
20. Subjects with history of hypo- and hyperthyroidism
21. Recent blood donation (<8 weeks)
22. Drink >14 units of alcohol per week on a regular basis
23. Consumption of recreational drugs
24. Current smokers (daily)
25. Medical history of difficulties in tolerating/undergoing study procedures planned in the present study, (e.g., like cannulation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Arm	Combination product: SPICE 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.
Placebo Comparator: Placebo-control arm	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean energy intake	Change in mean energy intake as measured via three consecutive 24-hour dietary recalls conducted online via Intake24, from week 0 to week 4.	week 0 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. ENERGY EXPENDITURE	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.	At Week 4 and 12
1. ENERGY EXPENDITURE	b) Overnight fasted energy expenditure and substrate oxidation using indirect calorimetry at week 4 and 12 (-20 - 0 min)	At Week 4 and 12
2. ENERGY INTAKE AND APPETITE	a) Energy intake: via 3 x 24h dietary recall (Intake24h).	At Week 12
2. ENERGY INTAKE AND APPETITE	c) Subjective appetite feelings: (individual questions and composite appetite score) via 100mm visual analogue scale (VAS) at -50, -40,15, 30, 60, 90, 120, 180 min relative to breakfast intake at week 4 and 12. The outcomes will be composite appetite score of iAUC3h of hunger, satiety, fullness, and desire to eat.	At Week 4 and 12
3. ANTHROPOMETRIC MEASURES	a) Body weight: At week 4 and 12. Units of measurement: Kg	At Week 4 and 12
3. ANTHROPOMETRIC MEASURES	b) Waist circumference: Units of measurement: cm	At Week 4 and 12
3. ANTHROPOMETRIC MEASURES	c) Body Mass Index (BMI): Units of measurement: kg/m^2	At Week 4 and 12
3. ANTHROPOMETRIC MEASURES	d) Body composition (bioelectrical impedance): Units of measurement: kg	At Week 4 and 12
4. SAFETY PROFILES	a) Gastrointestinal side effects: For the endpoint, measured using 100mm scale.	At Week 4 and 12
4. SAFETY PROFILES	b) Nausea: subjective feelings VAS at -50, -40, 15, 30, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC3h. Measured using 100mm scale.	At Week 4 and 12
4. SAFETY PROFILES	c) Heart rate: At -50, -40, 15, 30, 45, 60, 90,120, 180 min relative to breakfast intake for the endpoint iAUC3h. Units of measurement: bpm	At Week 4 and 12
4. SAFETY PROFILES	d) C-reactive protein: At -50 min (fasted) relative to breakfast intake for the endpoint. Units of measurement: mg/L	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	c) Fasting: HbA1c. Units of measurement: mmol/mol	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	e) Fasting: C-Reactive Protein: Units of measurement: mg/L	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	f) Fasting: Blood lipid profile. Units of measurement: mmol/L	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	g) Postprandial: gut hormones (GLP-1 at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement for GLP-1: pM	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	h) Postprandial: gut hormones (PYY at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement for PYY: pM	At Week 4 and 12
2. ENERGY INTAKE AND APPETITE	b) Ad libitum energy intake: via ad libitum homogeneous meal at 190 min timepoint at week 4 and 12. Food will be weighted before and after to calculate how much food was consumed and converted to kcal.	At Week 4 and 12
4. SAFETY PROFILES	e) Liver function: At -50 min fasted relative to breakfast intake for the endpoint. Units of measurement: g/l	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	d) Fasting: liver function: Units of measurement: g/L	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	i) Postprandial: gut hormones (Ghrelin) at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h at week 4 and 12. Units of measurement of Ghrelin: pg/mL	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	j) Postprandial: Glucose at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of glucose: mmol/L	At Week 4 and 12
5. METABOLIC BLOOD PROFILES	k) Postprandial: Insulin at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of Insulin: uU/mL or pM	Week 4 and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint: METABOLIC BLOOD PROFILES	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	Week 4 and 12
Exploratory Endpoint: METABOLIC BLOOD PROFILES	Postprandial: Gut hormone- Leptin at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of Leptin: ng/mL.	Week 4 and 12
Exploratory Endpoint: METABOLIC BLOOD PROFILES	Postprandial: Gut hormone: Growth differentiation factor 15 [GDF-15] at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of GDF-15: pg/mL	Week 4 and 12
Exploratory Endpoint: METABOLIC BLOOD PROFILES	Postprandial: Gut hormone- CCK at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of CCK:	Week 4 and 12
Exploratory Endpoint: METABOLIC BLOOD PROFILES	Postprandial: Gut hormone- Adiponectin at -50, -40,15, 30, 45, 60, 90, 120, 180 min relative to breakfast intake for the endpoint iAUC1h and iAUC3h. Units of measurement of Adiponectin:	Week 4 and 12

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Imperial College London; Imperial Clinical Trials Unit (ICTU)
• Investigators: Principal Investigator: Edward Chambers, Imperial College London, Department of Metabolism, Digestion and Reproduction

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 2402CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No