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
NCT02612259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2015-11-23
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
TRYPTOPHAN
at the dose of 3,5 m/kg/ day divided in two capsules
- OTHER
-
PLACEBO
at the dose of 3,5 m/kg/ day divided in two capsules
Sponsors & Collaborators
-
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Fundació Sant Joan de Déu
lead OTHER
Principal Investigators
-
Marta Ramón Krauel, PI · Hospital Sant Joan de Deu
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
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