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

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: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: TRYPTOPHAN; Other: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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.	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months
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	From baseline up to 6 months

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Marta Ramón Krauel, PI, Hospital Sant Joan de Deu

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: HSJD-OB-TRP; 2009-016921-32 (EudraCT Number)