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| Name | Class |
|---|---|
| Imperial College London | OTHER |
| Imperial Clinical Trials Unit (ICTU) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator |
| |
| Placebo-control arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria
Exclusion Criteria
Male and Female
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| Name | Affiliation | Role |
|---|---|---|
| Edward Chambers | Imperial College London, Department of Metabolism, Digestion and Reproduction | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust, Hammersmith Hospital, 72 Du Cane Rd | London | W12 0HS | United Kingdom |
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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.
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| 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. |
|
| 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 | 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 |
| 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 |
| 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 | c) Fasting: HbA1c. Units of measurement: mmol/mol | 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 | 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 |
| 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 |
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- 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 |
| 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 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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