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 | Completed Phase 2

• 2 other identifiers: HSJD-OB-TRP2009-016921-32
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• Change in weight by comparing the two groups

  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

  From baseline up to 6 months

• Change in systolic and diastolic blood pressure

  to achieve improvement of clinical parameters after 6 months of dietary supplementation with tryptophan and determine the difference between the two groups

  From baseline up to 6 months

• Change in Body mass index (BMI) defined as wt/ht2 by comparing the two groups

  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

  From baseline up to 6 months

• Change in waist/hip ratio by comparing the two groups

  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

  From baseline up to 6 months

• Change in Body Mass Index Z score (zBMI) by comparing the two groups

  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

  From baseline up to 6 months

Secondary Outcomes (20)

• change in total caloric (Kcal) consumption

  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

Study Arms (2)

TRYPTOPHAN

EXPERIMENTAL

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.

Dietary Supplement: TRYPTOPHAN

PLACEBO

PLACEBO COMPARATOR

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.

Other: PLACEBO

Interventions

TRYPTOPHAN DIETARY_SUPPLEMENT

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

TRYPTOPHAN

PLACEBO OTHER

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

Also known as: lactose capsules

PLACEBO

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Tryptophan; Lactose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Marta Ramón Krauel, PI

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 23, 2015
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 23, 2015

Record last verified: 2015-11