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Overweight and ObesitySPICENCT06689501

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

A study testing SPICE BLEND CAPSULE in people with Overweight and Obesity, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
SPICE BLEND CAPSULE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited Kingdom
Study dates
30 Oct 2024to 26 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 25Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd

    London, W12 0HS

Other trials in United Kingdom

About this study

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)

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.

Read more

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.

Read the 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.

Being tested
SPICE BLEND CAPSULE, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPICE BLEND CAPSULECombination product

    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.

  • PlaceboOther

    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.

Study groups in NCT06689501
Study groupRoleWhat they receive
Intervention ArmActive comparatorNot described
Receives: Combination Product: SPICE BLEND CAPSULE
Placebo-control armPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 0 to week 4

Secondary outcomes (23)

  1. 1. ENERGY EXPENDITURE

    1. 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.

    Measured: At Week 4 and 12

  2. 1. ENERGY EXPENDITURE

    1. Overnight fasted energy expenditure and substrate oxidation using indirect calorimetry at week 4 and 12 (-20 - 0 min)

    Measured: At Week 4 and 12

  3. 2. ENERGY INTAKE AND APPETITE

    1. Energy intake: via 3 x 24h dietary recall (Intake24h).

    Measured: At Week 12

  4. 2. ENERGY INTAKE AND APPETITE

    1. 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.

    Measured: At Week 4 and 12

  5. 2. ENERGY INTAKE AND APPETITE

    1. 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.

    Measured: At Week 4 and 12

  6. 3. ANTHROPOMETRIC MEASURES

    1. Body weight: At week 4 and 12. Units of measurement: Kg

    Measured: At Week 4 and 12

  7. 3. ANTHROPOMETRIC MEASURES

    1. Waist circumference: Units of measurement: cm

    Measured: At Week 4 and 12

  8. 3. ANTHROPOMETRIC MEASURES

    1. Body Mass Index (BMI): Units of measurement: kg/m^2

    Measured: At Week 4 and 12

  9. 3. ANTHROPOMETRIC MEASURES

    1. Body composition (bioelectrical impedance): Units of measurement: kg

    Measured: At Week 4 and 12

  10. 4. SAFETY PROFILES

    1. Gastrointestinal side effects: For the endpoint, measured using 100mm scale.

    Measured: At Week 4 and 12

  11. 4. SAFETY PROFILES

    1. 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.

    Measured: At Week 4 and 12

  12. 4. SAFETY PROFILES

    1. 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

    Measured: At Week 4 and 12

  13. 4. SAFETY PROFILES

    1. C-reactive protein: At -50 min (fasted) relative to breakfast intake for the endpoint. Units of measurement: mg/L

    Measured: At Week 4 and 12

  14. 4. SAFETY PROFILES

    1. Liver function: At -50 min fasted relative to breakfast intake for the endpoint. Units of measurement: g/l

    Measured: At Week 4 and 12

  15. 5. METABOLIC BLOOD PROFILES

    1. Fasting: HbA1c. Units of measurement: mmol/mol

    Measured: At Week 4 and 12

  16. 5. METABOLIC BLOOD PROFILES

    1. Fasting: liver function: Units of measurement: g/L

    Measured: At Week 4 and 12

  17. 5. METABOLIC BLOOD PROFILES

    1. Fasting: C-Reactive Protein: Units of measurement: mg/L

    Measured: At Week 4 and 12

  18. 5. METABOLIC BLOOD PROFILES

    1. Fasting: Blood lipid profile. Units of measurement: mmol/L

    Measured: At Week 4 and 12

  19. 5. METABOLIC BLOOD PROFILES

    1. 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

    Measured: At Week 4 and 12

  20. 5. METABOLIC BLOOD PROFILES

    1. 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

    Measured: At Week 4 and 12

  21. 5. METABOLIC BLOOD PROFILES

    1. 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

    Measured: At Week 4 and 12

  22. 5. METABOLIC BLOOD PROFILES

    1. 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

    Measured: At Week 4 and 12

  23. 5. METABOLIC BLOOD PROFILES

    1. 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

    Measured: Week 4 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start30 Oct 2024
  3. Primary completion26 Jun 2025
  4. Study completion26 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689501
Sponsor's protocol ID
2402CLI
Acronym
SPICE
Status last verified
Jul 2025
First submitted
23 Oct 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SPICE BLEND CAPSULE in people with Overweight and Obesity, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean energy intake (time frame: week 0 to week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06689501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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