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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016921-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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A phase II, randomized, double-blind, placebo-controlled, in parallel groups clinical trial to assess the safety and efficacy of dietary supplementation with tryptophan to achieve weight loss, and its neuropsychological effects in adolescents with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRYPTOPHAN | Experimental | tryptophan 3.5 mg / kg / day divided in 2 doses, one before breakfast and another one before dinner. Oral administration. Total treatment duration for each patient is 6 months. |
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| PLACEBO | Placebo Comparator | lactose capsules 3.5 mg / kg / day divided in 2 doses, one before breakfast and another one before dinner. Oral administration. Total treatment duration for each patient is 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRYPTOPHAN | Dietary Supplement | at the dose of 3,5 m/kg/ day divided in two capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight by comparing the two groups | to achieve weight loss using Linear Models for Multivariate Outcomes considering as a variables the number of visits, the gender and the group of each patient | From baseline up to 6 months |
| Change in systolic and diastolic blood pressure | to achieve improvement of clinical parameters after 6 months of dietary supplementation with tryptophan and determine the difference between the two groups | From baseline up to 6 months |
| Change in Body mass index (BMI) defined as wt/ht2 by comparing the two groups | to achieve weight loss using Linear Models for Multivariate Outcomes considering as a variables the number of visits, the gender and the group of each patient | From baseline up to 6 months |
| Change in waist/hip ratio by comparing the two groups | to achieve weight loss using Linear Models for Multivariate Outcomes considering as a variables the number of visits, the gender and the group of each patient | From baseline up to 6 months |
| Change in Body Mass Index Z score (zBMI) by comparing the two groups | to achieve weight loss using Linear Models for Multivariate Outcomes considering as a variables the number of visits, the gender and the group of each patient | From baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in total caloric (Kcal) consumption | to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group. | From baseline up to 6 months |
| Change in calorie consumption measuring weight loss (kcal/Kg/days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Ramón Krauel, PI | Hospital Sant Joan de Deu | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2015 | |
| Reset | Jan 20, 2016 | |
| Release | Apr 19, 2024 |
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| PLACEBO |
| Other |
at the dose of 3,5 m/kg/ day divided in two capsules |
|
|
to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group. |
| From baseline up to 6 months |
| Change in protein consumption | to achieve improvement of metabolic parameters, patient protein intake were measured during visit 1 and visit 7 and then proteins levels were compared with the control group. | From baseline up to 6 months |
| Total Percent of Calories From Protein | to achieve improvement of metabolic parameters, patient protein intake were measured during visit 1 and visit 7 and then proteins levels were compared with the control group. | From baseline up to 6 months |
| Total fat consumption | to achieve improvement of metabolic parameters, patient fat intake were measured (grams) during visit 1 and visit 7 and then fat levels were compared with the control group. | From baseline up to 6 months |
| Total Percent of Calories From Fat | to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group. | From baseline up to 6 months |
| Total carbohydrates consumption | to achieve improvement of metabolic parameters, patient carbohydrates intake were measured (grams of carbohydrates) during visit 1 and visit 7 and then carbohydrates levels were compared with the control group. | From baseline up to 6 months |
| the mean of lipids concentration (mg/dl) | to achieve improvement of metabolic parameters, the average amount of TSH were measured during visit 1 and visit 7 and then fat levels were compared with the control group. to achieve improvement of metabolic parameters, the average amount of lipids were measured during visit 1 and visit 7 and then fat levels were compared with the control group. The mean of cholesterol both LDL and HDL were considerate for the evaluation. | From baseline up to 6 months |
| the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L) | to evaluate the thyroid profile, the average amount of lipids were measured during visit 1 and visit 7 and then TSH levels were compared with the control group. | From baseline up to 6 months |
| the amount of thyroxine T4L concentration (pmol/L) | to evaluate the thyroid profile, the average amount of T4L were measured during visit 1 and visit 7 and then T4L levels were compared with the control group. | From baseline up to 6 months |
| the amount of creatinine levels (mg/dl) | to evaluate the hepatic profile, the average amount of creatinine were measured during visit 1 and visit 7 and then creatinine levels were compared with the control group. | From baseline up to 6 months |
| the amount of Alanine Aminotransferase (ALT) levels (mg/dl) | to assess the hepatic functionality, the average amount of ALT were measured during visit 1 and visit 7 and then ALT mean levels were compared with the control group. | From baseline up to 6 months |
| the amount of hemoglobin (g/dl) levels | to assess the renal functionality, the average amount of hemoglobin were measured during visit 1 and visit 7 and then hemoglobin mean levels were compared with the control group. | From baseline up to 6 months |
| Change in EuroQoL-5 score over 6 months supplement with tryptophan | to achieve improvement in depression and anxiety after tryptophan administration. Evaluation have been made during Visit 1 and vist 7 | From baseline up to 6 months |
| Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan | to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group | From baseline up to 6 months |
| Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan | to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group | From baseline up to 6 months |
| Change in the Eating Attitudes Test (EAT-40) score | the EAT-40 test is a widely used self-report questionnaire 40-item standardized self-report measure for the assessment of symptoms and concerns characteristic of eating disorders | From baseline up to 6 months |
| Change in State-Trait Depression Scales score | The State-Trait Personality Inventory (STPI) is a self-administered questionnaire, consists of eight 10-item subscales: state and trait anxiety, state and trait anger, state and trait curiosity, and state and trait depression. Results from the tryptophan group were compared with the placebo group | From baseline up to 6 months |
| Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration | For the safety and tolerance assessment of tryptophan supplementation in obese adolescents | From baseline up to 6 months |
| Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration | For the safety and tolerance assessment of tryptophan supplementation in obese adolescents | From baseline up to 6 months |
| Reset | Sep 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2015 | Jan 20, 2016 | |||
| Apr 19, 2024 | Sep 12, 2024 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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| ID | Term |
|---|---|
| D014364 | Tryptophan |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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