Investigating a blend of supplements for energy balance 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)
This study is testing if a mix of supplements can help overweight adults eat less and burn more energy over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Société des Produits Nestlé (SPN) Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06689501 on ClinicalTrials.gov |
What this trial studies
This trial examines the effects of a combination of L-carnitine tartrate, dihydrocapsiate, and protein yeast hydrolysate on energy intake and expenditure in overweight and obese adults over a 12-week period. It is a single-centre, double-blind, randomized, placebo-controlled trial involving approximately 44 participants who will be assigned to either the study product or a placebo. Participants will take four capsules daily and their dietary intake will be monitored through online recalls. The study aims to determine if this combination can effectively promote a negative energy balance by decreasing appetite and increasing energy expenditure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 with a BMI between 28-32 kg/m2 or 25-30 kg/m2 for South-Asian ethnicities.
Not a fit: Patients with significant weight changes in the past six months or those on restrictive diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to managing weight and preventing weight regain in overweight and obese individuals.
How similar studies have performed: While individual ingredients have shown promise, this specific combination has not been previously tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
London
- Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Edward Chambers — Imperial College London, Department of Metabolism, Digestion and Reproduction
- Study coordinator: Jennifer Pugh
- Email: J.pugh@imperial.ac.uk
- Phone: +447786361040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.