obesity MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: TRIPTOFANO
Pharmaceutical Form: Capsule
INN or Proposed INN: TRIPTOFANO
CAS Number: 73-22-3
Other descriptive name: TRYPTOPHAN
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Fundació Sant Joan de Déu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both male and female patients, attending the Pediatric Endocrinology Service on an out-patient basis. 2. Age from 12 to 17 years, inclusively. 3. Presence of a BMI > or = to 2SD and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Obesity secondary to an endocrine disease (hypothyroidism, Cushing?s syndrome, polycystic ovary, hypothalamic syndromes, hypogonadism) or the use of medications such as cortisol. 2. Concomitant administration of other psychotrophic medication such as antidepressants or anxiolytics. 3. Patients included in the study must not be taking any vitamins or nutritional supplements or any anti-obesity preparations, including herbal remedies, pharmacy products or homeopathic products. 4. Patients with a known psychiatric disorder. 5. Patients treated with any kind of structured psychotherapy regime. 6. Patients with type 2 DM, arterial hypertension (blood pressure above the 95 percentile for gender and height) or steatotic liver (hypertransaminasemia with echographic image of fatty liver). 7. Patients with any severe food intolerance, or with a known allergy to any of the substances used in the study. 8. Patients in treatment with oral hypoglycemiants. 9. Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a treatment of dietary supplementation with tryptophan to achieve weight loss, and the improvement of clinical parameters such as reduced body mass index and waist/hip ratio.;Secondary Objective: 1. To determine whether the administration of tryptophan as a dietary supplement helps to control intake, reducing the total number of calories consumed, and also the intake of carbohydrates throughout the day. 2. To assess the impact of tryptophan supplementation at reducing symptoms of anxiety, depression and other symptoms associated with eating disorders. 3. To determine tolerance of tryptophan as a dietary supplement in obese adolescents and its effects on plasma tryptophan levels, tryptophan/LNNAs ratio, and plasmatic serotonin.;Primary end point(s): The following clinical variables will be studied: weight, height, BMI, weight/height Z-scores, BMI Z-score, and height/blood pressure and waist/hip circumference Z-scores.;Timepoint(s) of evaluation of this end point: These parameters will be measured before starting the study and every month for the following six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See protocol (variables associated with secondary objectives).;Timepoint(s) of evaluation of this end point: See protocol (variables associated with secondary objectives). | — |
Countries
Spain
Contacts
Public ContactFundació Sant Joan de Déu
Fundació Sant Joan de Déu
Outcome results
None listed