Clinical trial NCT02612259: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-11-23
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 \< 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.

Primary outcomes:
measure: Change in weight by comparing the two groups
timeFrame: From baseline up to 6 months
measure: Change in systolic and diastolic blood pressure
timeFrame: From baseline up to 6 months
measure: Change in Body mass index (BMI) defined as wt/ht2 by comparing the two groups
timeFrame: From baseline up to 6 months
measure: Change in waist/hip ratio by comparing the two groups
timeFrame: From baseline up to 6 months
measure: Change in Body Mass Index Z score (zBMI) by comparing the two groups
timeFrame: From baseline up to 6 months
Secondary outcomes:
measure: change in total caloric (Kcal) consumption
timeFrame: From baseline up to 6 months
measure: Change in calorie consumption measuring weight loss (kcal/Kg/days)
timeFrame: From baseline up to 6 months
measure: Change in protein consumption
timeFrame: From baseline up to 6 months
measure: Total Percent of Calories From Protein
timeFrame: From baseline up to 6 months
measure: Total fat consumption
timeFrame: From baseline up to 6 months
measure: Total Percent of Calories From Fat
timeFrame: From baseline up to 6 months
measure: Total carbohydrates consumption
timeFrame: From baseline up to 6 months
measure: the mean of lipids concentration (mg/dl)
timeFrame: From baseline up to 6 months
measure: the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)
timeFrame: From baseline up to 6 months
measure: the amount of thyroxine T4L concentration (pmol/L)
timeFrame: From baseline up to 6 months
measure: the amount of creatinine levels (mg/dl)
timeFrame: From baseline up to 6 months
measure: the amount of Alanine Aminotransferase (ALT) levels (mg/dl)
timeFrame: From baseline up to 6 months
measure: the amount of hemoglobin (g/dl) levels
timeFrame: From baseline up to 6 months
measure: Change in EuroQoL-5 score over 6 months supplement with tryptophan
timeFrame: From baseline up to 6 months
measure: Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan
timeFrame: From baseline up to 6 months
measure: Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan
timeFrame: From baseline up to 6 months
measure: Change in the Eating Attitudes Test (EAT-40) score
timeFrame: From baseline up to 6 months
measure: Change in State-Trait Depression Scales score
timeFrame: From baseline up to 6 months
measure: Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration
timeFrame: From baseline up to 6 months
measure: Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration
timeFrame: From baseline up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Sant Joan de Deu
name: Marta Ramón Krauel, PI
role: PRINCIPAL_INVESTIGATOR
References: