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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

NCT ID: NCT02612259

Last Updated: 2015-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TRYPTOPHAN

tryptophan 3.5 mg / kg / day divided in 2 doses, one before breakfast and another one before dinner. Oral administration.

Total treatment duration for each patient is 6 months.

Group Type EXPERIMENTAL

TRYPTOPHAN

Intervention Type DIETARY_SUPPLEMENT

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

PLACEBO

lactose capsules 3.5 mg / kg / day divided in 2 doses, one before breakfast and another one before dinner. Oral administration.

Total treatment duration for each patient is 6 months.

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

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

Interventions

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TRYPTOPHAN

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

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

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

Intervention Type OTHER

Other Intervention Names

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lactose capsules

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Ramón Krauel, PI

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Joan de Deu

Other Identifiers

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2009-016921-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HSJD-OB-TRP

Identifier Type: -

Identifier Source: org_study_id