Back to resultsA 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
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TRYPTOPHAN
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TRYPTOPHAN
PLACEBO
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
change in total caloric (Kcal) consumption
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.
Change in calorie consumption measuring weight loss (kcal/Kg/days)
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.
Change in protein consumption
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.
Total Percent of Calories From Protein
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.
Total fat consumption
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.
Total Percent of Calories From Fat
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.
Total carbohydrates consumption
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.
the mean of lipids concentration (mg/dl)
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.
the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)
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.
the amount of thyroxine T4L concentration (pmol/L)
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.
the amount of creatinine levels (mg/dl)
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.
the amount of Alanine Aminotransferase (ALT) levels (mg/dl)
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.
the amount of hemoglobin (g/dl) levels
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.
Change in EuroQoL-5 score over 6 months supplement with tryptophan
to achieve improvement in depression and anxiety after tryptophan administration. Evaluation have been made during Visit 1 and vist 7
Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
Change in the Eating Attitudes Test (EAT-40) score
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
Change in State-Trait Depression Scales score
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
Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
Full Information
NCT ID
NCT02612259
First Posted
November 17, 2015
Last Updated
November 19, 2015
Sponsor
Fundació Sant Joan de Déu
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02612259
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRYPTOPHAN
Arm Type
Experimental
Arm 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.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
TRYPTOPHAN
Intervention Description
at the dose of 3,5 m/kg/ day divided in two capsules
Intervention Type
Other
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
lactose capsules
Intervention Description
at the dose of 3,5 m/kg/ day divided in two capsules
Primary Outcome Measure Information:
Title
Change in weight by comparing the two groups
Description
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
Time Frame
From baseline up to 6 months
Title
Change in systolic and diastolic blood pressure
Description
to achieve improvement of clinical parameters after 6 months of dietary supplementation with tryptophan and determine the difference between the two groups
Time Frame
From baseline up to 6 months
Title
Change in Body mass index (BMI) defined as wt/ht2 by comparing the two groups
Description
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
Time Frame
From baseline up to 6 months
Title
Change in waist/hip ratio by comparing the two groups
Description
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
Time Frame
From baseline up to 6 months
Title
Change in Body Mass Index Z score (zBMI) by comparing the two groups
Description
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
Time Frame
From baseline up to 6 months
Secondary Outcome Measure Information:
Title
change in total caloric (Kcal) consumption
Description
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.
Time Frame
From baseline up to 6 months
Title
Change in calorie consumption measuring weight loss (kcal/Kg/days)
Description
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.
Time Frame
From baseline up to 6 months
Title
Change in protein consumption
Description
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.
Time Frame
From baseline up to 6 months
Title
Total Percent of Calories From Protein
Description
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.
Time Frame
From baseline up to 6 months
Title
Total fat consumption
Description
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.
Time Frame
From baseline up to 6 months
Title
Total Percent of Calories From Fat
Description
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.
Time Frame
From baseline up to 6 months
Title
Total carbohydrates consumption
Description
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.
Time Frame
From baseline up to 6 months
Title
the mean of lipids concentration (mg/dl)
Description
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.
Time Frame
From baseline up to 6 months
Title
the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)
Description
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.
Time Frame
From baseline up to 6 months
Title
the amount of thyroxine T4L concentration (pmol/L)
Description
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.
Time Frame
From baseline up to 6 months
Title
the amount of creatinine levels (mg/dl)
Description
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.
Time Frame
From baseline up to 6 months
Title
the amount of Alanine Aminotransferase (ALT) levels (mg/dl)
Description
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.
Time Frame
From baseline up to 6 months
Title
the amount of hemoglobin (g/dl) levels
Description
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.
Time Frame
From baseline up to 6 months
Title
Change in EuroQoL-5 score over 6 months supplement with tryptophan
Description
to achieve improvement in depression and anxiety after tryptophan administration. Evaluation have been made during Visit 1 and vist 7
Time Frame
From baseline up to 6 months
Title
Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan
Description
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
Time Frame
From baseline up to 6 months
Title
Change in Children's Manifest Anxiety scale (CMAS) score over 6 months supplement with tryptophan
Description
to achieve improvement in depression and anxiety by comparing the tryptophan group with the placebo group
Time Frame
From baseline up to 6 months
Title
Change in the Eating Attitudes Test (EAT-40) score
Description
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
Time Frame
From baseline up to 6 months
Title
Change in State-Trait Depression Scales score
Description
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
Time Frame
From baseline up to 6 months
Title
Change in Tryptophan plasma level in obese adolescent after 6 months tryptophan administration
Description
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
Time Frame
From baseline up to 6 months
Title
Change in Tryptophan/Large neutral aminoacid (LNNA) ratio in obese adolescent plasma after 6 months of tryptophan administration
Description
For the safety and tolerance assessment of tryptophan supplementation in obese adolescents
Time Frame
From baseline up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Ramón Krauel, PI
Organizational Affiliation
Hospital Sant Joan de Deu
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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
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