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

F

Fundació Sant Joan de Déu

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Other: PLACEBO
Dietary Supplement: TRYPTOPHAN

Study type

Interventional

Funder types

Other

Identifiers

NCT02612259
HSJD-OB-TRP
2009-016921-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups, including a placebo group

TRYPTOPHAN
Experimental group
Description:
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.
Treatment:
Dietary Supplement: TRYPTOPHAN
PLACEBO
Placebo Comparator group
Description:
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.
Treatment:
Other: PLACEBO

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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