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

November 19, 2015 updated by: Fundació Sant Joan de Déu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Dietary supplement: TRYPTOPHAN
at the dose of 3,5 m/kg/ day divided in two capsules
Placebo Comparator: 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.
Other: PLACEBO
at the dose of 3,5 m/kg/ day divided in two capsules
Other Names:
  • lactose capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in weight by comparing the two groups
Time Frame: From baseline up to 6 months
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
Time Frame: From baseline up to 6 months
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
Time Frame: From baseline up to 6 months
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
Time Frame: From baseline up to 6 months
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
Time Frame: From baseline up to 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in total caloric (Kcal) consumption
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group.
From baseline up to 6 months
Change in calorie consumption measuring weight loss (kcal/Kg/days)
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group.
From baseline up to 6 months
Change in protein consumption
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient protein intake were measured during visit 1 and visit 7 and then proteins levels were compared with the control group.
From baseline up to 6 months
Total Percent of Calories From Protein
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient protein intake were measured during visit 1 and visit 7 and then proteins levels were compared with the control group.
From baseline up to 6 months
Total fat consumption
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient fat intake were measured (grams) during visit 1 and visit 7 and then fat levels were compared with the control group.
From baseline up to 6 months
Total Percent of Calories From Fat
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient calories intake were measured during visit 1 and visit 7 and then calories levels were compared with the control group.
From baseline up to 6 months
Total carbohydrates consumption
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, patient carbohydrates intake were measured (grams of carbohydrates) during visit 1 and visit 7 and then carbohydrates levels were compared with the control group.
From baseline up to 6 months
the mean of lipids concentration (mg/dl)
Time Frame: From baseline up to 6 months
to achieve improvement of metabolic parameters, the average amount of TSH were measured during visit 1 and visit 7 and then fat levels were compared with the control group. to achieve improvement of metabolic parameters, the average amount of lipids were measured during visit 1 and visit 7 and then fat levels were compared with the control group. The mean of cholesterol both LDL and HDL were considerate for the evaluation.
From baseline up to 6 months
the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)
Time Frame: From baseline up to 6 months
to evaluate the thyroid profile, the average amount of lipids were measured during visit 1 and visit 7 and then TSH levels were compared with the control group.
From baseline up to 6 months
the amount of thyroxine T4L concentration (pmol/L)
Time Frame: From baseline up to 6 months
to evaluate the thyroid profile, the average amount of T4L were measured during visit 1 and visit 7 and then T4L levels were compared with the control group.
From baseline up to 6 months
the amount of creatinine levels (mg/dl)
Time Frame: From baseline up to 6 months
to evaluate the hepatic profile, the average amount of creatinine were measured during visit 1 and visit 7 and then creatinine levels were compared with the control group.
From baseline up to 6 months
the amount of Alanine Aminotransferase (ALT) levels (mg/dl)
Time Frame: From baseline up to 6 months
to assess the hepatic functionality, the average amount of ALT were measured during visit 1 and visit 7 and then ALT mean levels were compared with the control group.
From baseline up to 6 months
the amount of hemoglobin (g/dl) levels
Time Frame: From baseline up to 6 months
to assess the renal functionality, the average amount of hemoglobin were measured during visit 1 and visit 7 and then hemoglobin mean levels were compared with the control group.
From baseline up to 6 months
Change in EuroQoL-5 score over 6 months supplement with tryptophan
Time Frame: From baseline up to 6 months
to achieve improvement in depression and anxiety after tryptophan administration. Evaluation have been made during Visit 1 and vist 7
From baseline up to 6 months
Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan
Time Frame: From baseline up to 6 months
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
From baseline up to 6 months
Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan
Time Frame: From baseline up to 6 months
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
From baseline up to 6 months
Change in the Eating Attitudes Test (EAT-40) score
Time Frame: From baseline up to 6 months
the EAT-40 test is a widely used self-report questionnaire 40-item standardized self-report measure for the assessment of symptoms and concerns characteristic of eating disorders
From baseline up to 6 months
Change in State-Trait Depression Scales score
Time Frame: From baseline up to 6 months
The State-Trait Personality Inventory (STPI) is a self-administered questionnaire, consists of eight 10-item subscales: state and trait anxiety, state and trait anger, state and trait curiosity, and state and trait depression. Results from the tryptophan group were compared with the placebo group
From baseline up to 6 months
Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration
Time Frame: From baseline up to 6 months
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
From baseline up to 6 months
Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration
Time Frame: From baseline up to 6 months
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
From baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Sant Joan de Déu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Salud Carlos III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta Ramón Krauel, PI, Hospital Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSJD-OB-TRP
  • 2009-016921-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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