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 Adolescent Patients Age 12 to 17 Years With Obesity
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 44
- Primary Endpoint
- Change in weight by comparing the two groups
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both male and female patients, attending the Pediatric Endocrinology Service on an out-patient basis.
- •Age from 12 to 17 years, inclusively.
- •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)
- •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.
- •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.
- •The informed consent of the parents or legal representative and of the young adults is required.
Exclusion Criteria
- •Obesity secondary to an endocrine disease (hypothyroidism, Cushing?s syndrome, polycystic ovary, hypothalamic syndromes, hypogonadism) or the use of medications such as cortisol.
- •Concomitant administration of other psychotrophic medication such as antidepressants or anxiolytics.
- •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.
- •Patients with a known psychiatric disorder.
- •Patients treated with any kind of structured psychotherapy regime.
- •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).
- •Patients with any severe food intolerance, or with a known allergy to any of the substances used in the study.
- •Patients in treatment with oral hypoglycemiants.
- •Pregnant or breast-feeding.
Outcomes
Primary Outcomes
Change in weight by comparing the two groups
Time Frame: From baseline up to 6 months
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
Change in systolic and diastolic blood pressure
Time Frame: From baseline up to 6 months
to achieve improvement of clinical parameters after 6 months of dietary supplementation with tryptophan and determine the difference between the two groups
Change in Body mass index (BMI) defined as wt/ht2 by comparing the two groups
Time Frame: From baseline up to 6 months
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
Change in waist/hip ratio by comparing the two groups
Time Frame: From baseline up to 6 months
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
Change in Body Mass Index Z score (zBMI) by comparing the two groups
Time Frame: From baseline up to 6 months
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
Secondary Outcomes
- change in total caloric (Kcal) consumption(From baseline up to 6 months)
- the mean of lipids concentration (mg/dl)(From baseline up to 6 months)
- the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)(From baseline up to 6 months)
- the amount of thyroxine T4L concentration (pmol/L)(From baseline up to 6 months)
- the amount of creatinine levels (mg/dl)(From baseline up to 6 months)
- the amount of Alanine Aminotransferase (ALT) levels (mg/dl)(From baseline up to 6 months)
- the amount of hemoglobin (g/dl) levels(From baseline up to 6 months)
- Change in EuroQoL-5 score over 6 months supplement with tryptophan(From baseline up to 6 months)
- Change in calorie consumption measuring weight loss (kcal/Kg/days)(From baseline up to 6 months)
- Change in protein consumption(From baseline up to 6 months)
- Total Percent of Calories From Protein(From baseline up to 6 months)
- Total fat consumption(From baseline up to 6 months)
- Total Percent of Calories From Fat(From baseline up to 6 months)
- Total carbohydrates consumption(From baseline up to 6 months)
- Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan(From baseline up to 6 months)
- Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan(From baseline up to 6 months)
- Change in the Eating Attitudes Test (EAT-40) score(From baseline up to 6 months)
- Change in State-Trait Depression Scales score(From baseline up to 6 months)
- Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration(From baseline up to 6 months)
- Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration(From baseline up to 6 months)