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

NCT06689501 | Completed

• 1 other identifier: 2402CLI
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (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.

  week 0 to week 4

Secondary Outcomes (23)

• 1. ENERGY EXPENDITURE

  At Week 4 and 12

• 1. ENERGY EXPENDITURE

  At Week 4 and 12

• 2. ENERGY INTAKE AND APPETITE

  At Week 12

• 2. ENERGY INTAKE AND APPETITE

  At Week 4 and 12

• 2. ENERGY INTAKE AND APPETITE

  At Week 4 and 12

Other Outcomes (5)

• Exploratory Endpoint: METABOLIC BLOOD PROFILES

  Week 4 and 12

• Exploratory Endpoint: METABOLIC BLOOD PROFILES

  Week 4 and 12

• Exploratory Endpoint: METABOLIC BLOOD PROFILES

  Week 4 and 12

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Combination Product: SPICE BLEND CAPSULE

Placebo-control arm

PLACEBO COMPARATOR

Other: Placebo

Interventions

SPICE BLEND CAPSULE COMBINATION_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.

Intervention Arm

Placebo OTHER

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.

Placebo-control arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Known food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Imperial College London: collaborator
• Imperial Clinical Trials Unit (ICTU): collaborator

Study Sites (1)

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

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Chambers

  Imperial College London, Department of Metabolism, Digestion and Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 14, 2024
• Study Start: October 30, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)