ObesityPhase 2NCT02612259
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 2 study testing TRYPTOPHAN in people with Obesity, run by Fundació Sant Joan de Déu.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- TRYPTOPHAN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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
- Being tested
- TRYPTOPHAN, PLACEBO
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRYPTOPHANDietary supplement
at the dose of 3,5 m/kg/ day divided in two capsules
PLACEBOOther
Also called lactose capsules
at the dose of 3,5 m/kg/ day divided in two capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline up to 6 months
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Marta Ramón Krauel, PI, Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612259
- Sponsor's protocol ID
- HSJD-OB-TRP
- Other IDs
- 2009-016921-32, 2009
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02612259
- Acronym / sponsor ID
- HSJD-OB-TRP
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRYPTOPHAN | Experimental | Dietary Supplement: TRYPTOPHANtryptophan 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. |
| PLACEBO | Placebo comparator | Other: PLACEBOlactose 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRYPTOPHANat the dose of 3,5 m/kg/ day divided in two capsules | Dietary supplement | TRYPTOPHAN |
| PLACEBOAlso: lactose capsulesat the dose of 3,5 m/kg/ day divided in two capsules | Other | PLACEBO |
Primary outcome
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
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
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
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
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
20 secondary outcomes
change in total caloric (Kcal) consumption
Time frame: From baseline up to 6 months
Change in calorie consumption measuring weight loss (kcal/Kg/days)
Time frame: From baseline up to 6 months
Change in protein consumption
Time frame: From baseline up to 6 months
Total Percent of Calories From Protein
Time frame: From baseline up to 6 months
Total fat consumption
Time frame: From baseline up to 6 months
Total Percent of Calories From Fat
Time frame: From baseline up to 6 months
Total carbohydrates consumption
Time frame: From baseline up to 6 months
the mean of lipids concentration (mg/dl)
Time frame: From baseline up to 6 months
the amount of Thyroid-stimulating hormone (TSH) concentration (mU/L)
Time frame: From baseline up to 6 months
the amount of thyroxine T4L concentration (pmol/L)
Time frame: From baseline up to 6 months
the amount of creatinine levels (mg/dl)
Time frame: From baseline up to 6 months
the amount of Alanine Aminotransferase (ALT) levels (mg/dl)
Time frame: From baseline up to 6 months
the amount of hemoglobin (g/dl) levels
Time frame: 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
Change in the Clinical Global Impressions (CGI) Scale score over 6 months supplement with tryptophan
Time frame: 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
Change in the Eating Attitudes Test (EAT-40) score
Time frame: From baseline up to 6 months
Change in State-Trait Depression Scales score
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Ramón Krauel, PI principal investigator
Hospital Sant Joan de Deu
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRYPTOPHAN in people with Obesity, run by Fundació Sant Joan de Déu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight by comparing the two groups (time frame: From baseline up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.