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

Fundació Sant Joan de Déu44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obesity

Interventions

TRYPTOPHANDIETARY_SUPPLEMENT

at the dose of 3,5 m/kg/ day divided in two capsules

PLACEBOOTHER

at the dose of 3,5 m/kg/ day divided in two capsules

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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 \< or = to 4SD (standard deviations) for their age and sex (Spanish cross-sectional growth reference tables of 2008) 4. Patients must have an educational level that permits adequate communication and must agree to cooperate in all the tests and examinations included in the protocol. 5. Subjects of reproductive potential must use an effective birth control method during the study. Women of reproductive age will be recruited after a negative pregnancy test. 6. The informed consent of the parents or legal representative and of the young adults is required. 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.

Outcomes

Primary Outcomes

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