Fact CheckerSign in

NCT06689501Completed

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

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)

Source: ClinicalTrials.gov · Last updated 11 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
44 (actual)
First submitted
23 Oct 2024
Start date
30 Oct 2024
Primary completion date
26 Jun 2025
Lead sponsor
Société des Produits Nestlé (SPN)
Diseases
Obesity
NCT number
NCT06689501

What you commit to

  • Study type: Interventional
  • Participants enrolled: 44
  • From 30 Oct 2024 to the primary completion date, 26 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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)
  • Consumption of recreational drugs

Other illness

  • Eating behaviour disorders such as emotional, restrained or external eating determined via Dutch Eating Behaviour Questionnaire (DEBQ).
  • Known food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
  • Chronic metabolic disease (except high cholesterol)
  • History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
  • 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
  • Medical history of difficulties in tolerating/undergoing study procedures planned in the present study, (e.g., like cannulation)

Lab values

  • Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)

Other

  • Weight change of ≥3 kg in the preceding 6 months
  • 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 congenital dysfunction of specific organic cation carnitine transporter OCTN2
  • Anaemia
  • Pregnancy or lactation
  • Life expectancy less than 1 year
  • Recent blood donation (\<8 weeks)
  • Drink \>14 units of alcohol per week on a regular basis
  • Current smokers (daily)

Who the study is looking for

  • 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

Age in the registry: 21 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.