Obesity in ChildhoodNCT03670875
Non-Pharmacologic Alternatives for Childhood Obesity
A study testing Agave inulin, Curcumin and O3FA in people with Obesity in Childhood, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Obesity in Childhood
- What is being tested?
- Agave inulin, Curcumin and O3FA
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- 31 Jul 2021to 30 Dec 2022
- Phase
- Interventional
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gender: Boys and Girls
- Diagnosis of obesity (percentile ≥ 95% according to The Centers for Disease Control and Prevention growth charts)
- Informed consent of parents
- Informed assent of the participant
Who cannot join
- Diabetes
- Thyroid disease
- Renal disease
- Hepatic disease
- Neoplasia disease
- Chronic gastrointestinal conditions
Show all 10Show fewer
- Consume of prebiotics or probiotics
- Consume of prebiotics or food supplements
- Use of anti-inflammatory drugs.
- Recent use of antibiotics (30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Pharmacologic Alternatives for the Treatment of Childhood Obesity in Mexico
Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Animal models and clinical trials in adults have provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin, and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological alternatives could support diet and exercise to decrease the weight of children with obesity.
Read the detailed description
The aim of this study is to determinate the efficacy and safety of agave inulin, curcumin, and omega-3 fatty acids (O3FA) to decrease the weight of children with obesity.
Design. Randomized controlled clinical trial (RCT) with four study groups: agave inulin, curcumin, omega-3 fatty acids and a control group. All groups will receive instructions to decrease calories intake and do exercise.
Children sent to the unit with a presumptive diagnosis of obesity will be considered as candidates to the RCT. Children accomplishing with inclusion/exclusion criteria will be randomized to one of the study groups.
Sample size was calculated using a statistical power of 80%, alpha value of 0.05. A 15 % of difference, in the mean of weight reduction, between control group and intervention groups was considered. The estimated sample size was 75 subjects for each group.
Weight, height, BMI, blood pressure, abdominal circumference and body fat percentage will be measured in months 0, 1, 2, and 3. In months 0 and 3 a fasting venous blood sample will be drawn to perform the following test: glucose, insulin, lipid profile and C- Reactive protein, aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Anthropometric measures, food intake recommendation and diaries of food consume will be performed by trained nutritionists. Recommendation about type of exercise and estimation of calories consumed will be performed by a physical education teacher.
The statistical analysis will performed by one to the investigators blinded to treatment groups. Numerical values will be expressed as mean ± standard deviation. Categorical variables will be expressed as proportions. The analysis will be preformed according with CONSORT group recommendations Differences between the groups were estimated using one-way ANOVA with Bonferroni post-hoc test for numerical parameters and χ 2 test for categorical variables. Intragroup differences will be assessed by paired Student t test (Mann-Whitney U test for skewed data). Statistical significance will be considered as a p value <0.05 and 95% confidence interval (CI). Statistical Package for the Social Sciences will be used for the analysis
- Conditions
- Obesity in Childhood
- Being tested
- Agave inulin, Curcumin, O3FA, Control
- Keywords
- Children, obesity, agave-inulin, curcumin, O3FA
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agave inulinDietary supplement
Will be provided in dehydrated apple cubes
CurcuminDietary supplement
Also called Turmeric
Will be provided in capsules
O3FADietary supplement
Will be provided in capsules
ControlBehavioural
Dietary recommendations to ingest 1600 calories per day. Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
| Study group | Role | What they receive |
|---|---|---|
| Agave inulin | Experimental | Agave inulin 2.3 g, by mouth, every 12 hours for 3 months. Plus recommendations to decrease calories intake an do exercise. Receives: Dietary Supplement: Agave inulin |
| Curcumin | Experimental | Curcumin 600 mg (turmeric 600 + black pepper 5 mg) by mouth, daily for 3 months. Plus recommendations to decrease calories intake an do exercise. Receives: Dietary Supplement: Curcumin |
| Omega 3 Fatty Acids | Experimental | O3FA 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth, every 8 hours for 3 months. Plus recommendations to decrease calories intake an do exercise. Receives: Dietary Supplement: O3FA |
| Control | Other | Recommendations to decrease calories intake an do exercise. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loosing weight
Weight lost between basal and third month visits. Determined by a digital scale
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start31 Jul 2021
- Primary completion31 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Obesity in ChildhoodStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study groups. Agave inulin: 2.3 g twice a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise. Curcumin: 600 mg (turmeric 600 + black pepper 5 mg) by mouth daily during 3 months plus recommendations to decrease calories intake an do exercise. Omega-3 fatty acids 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise. Control group with no intervention. Recommendations to decrease calories intake an do exercise. Dietary recommendations to ingest 1600 calories per day Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico
- Investigators
- Fernando Guerrero, PhD, Principal investigator, Instituto Mexicano del Seguro SocialGerardo Martinez, PhD, Study director, Instituto Mexicano del Seguro SocialLuis E Simental, PhD, Study chair, Instituto Mexicano del Seguro SocialClaudia I Gamboa, PhD, Study chair, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670875
- Sponsor's protocol ID
- R-2016-785-103
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gluckman P, Nishtar S, Armstrong T. Ending childhood obesity: a multidimensional challenge. Lancet. 2015 Mar 21;385(9973):1048-50. doi: 10.1016/S0140-6736(15)60509-8. No abstract available.
PubMed 25797547Siro I, Kapolna E, Kapolna B, Lugasi A. Functional food. Product development, marketing and consumer acceptance--a review. Appetite. 2008 Nov;51(3):456-67. doi: 10.1016/j.appet.2008.05.060. Epub 2008 Jun 4.
PubMed 18582508Tomaschunas M, Zorb R, Fischer J, Kohn E, Hinrichs J, Busch-Stockfisch M. Changes in sensory properties and consumer acceptance of reduced fat pork Lyon-style and liver sausages containing inulin and citrus fiber as fat replacers. Meat Sci. 2013 Nov;95(3):629-40. doi: 10.1016/j.meatsci.2013.06.002. Epub 2013 Jun 10.
PubMed 23811098Mancilla-Margalli NA, Lopez MG. Water-soluble carbohydrates and fructan structure patterns from Agave and Dasylirion species. J Agric Food Chem. 2006 Oct 4;54(20):7832-9. doi: 10.1021/jf060354v.
PubMed 17002459González-Herrera SM, Rutiaga-Quiñones OM, Aguilar CN, et al. Dehydrated Apple matrix supplemented with agave fructans, inulin and oligofructose. LWT Food Science and Technology. 2016;65:1059-1065.
Lopez-Velazquez G, Diaz-Garcia L, Anzo A, Parra-Ortiz M, Llamosas-Gallardo B, Ortiz-Hernandez AA, Mancilla-Ramirez J, Cruz-Rubio JM, Gutierrez-Castrellon P. Safety of a dual potential prebiotic system from Mexican agave "Metlin(R) and Metlos(R)", incorporated to an infant formula for term newborn babies: a randomized controlled trial. Rev Invest Clin. 2013 Nov-Dec;65(6):483-90.
PubMed 24687355Wang SL, Li Y, Wen Y, Chen YF, Na LX, Li ST, Sun CH. Curcumin, a potential inhibitor of up-regulation of TNF-alpha and IL-6 induced by palmitate in 3T3-L1 adipocytes through NF-kappaB and JNK pathway. Biomed Environ Sci. 2009 Feb;22(1):32-9. doi: 10.1016/S0895-3988(09)60019-2.
PubMed 19462685Sahebkar A. Why it is necessary to translate curcumin into clinical practice for the prevention and treatment of metabolic syndrome? Biofactors. 2013 Mar-Apr;39(2):197-208. doi: 10.1002/biof.1062. Epub 2012 Dec 13.
PubMed 23239418Ramirez-Bosca A, Soler A, Carrion MA, Diaz-Alperi J, Bernd A, Quintanilla C, Quintanilla Almagro E, Miquel J. An hydroalcoholic extract of curcuma longa lowers the apo B/apo A ratio. Implications for atherogenesis prevention. Mech Ageing Dev. 2000 Oct 20;119(1-2):41-7. doi: 10.1016/s0047-6374(00)00169-x.
PubMed 11040400Nagwa I, Ragab S, Baky A, et al. Effect of Oral Curcumin Administration on Insulin Resistance, Serum Resistin and Fetuin-A in Obese Children: Randomized Placebo- Controlled study. Reser J of Pharm, Biol and Chem Sci 2014 5:887-96
Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d.
PubMed 23059643Huang XF, Xin X, McLennan P, Storlien L. Role of fat amount and type in ameliorating diet-induced obesity: insights at the level of hypothalamic arcuate nucleus leptin receptor, neuropeptide Y and pro-opiomelanocortin mRNA expression. Diabetes Obes Metab. 2004 Jan;6(1):35-44. doi: 10.1111/j.1463-1326.2004.00312.x.
PubMed 14686961Couet C, Delarue J, Ritz P, Antoine JM, Lamisse F. Effect of dietary fish oil on body fat mass and basal fat oxidation in healthy adults. Int J Obes Relat Metab Disord. 1997 Aug;21(8):637-43. doi: 10.1038/sj.ijo.0800451.
PubMed 15481762Juarez-Lopez C, Klunder-Klunder M, Madrigal-Azcarate A, Flores-Huerta S. Omega-3 polyunsaturated fatty acids reduce insulin resistance and triglycerides in obese children and adolescents. Pediatr Diabetes. 2013 Aug;14(5):377-83. doi: 10.1111/pedi.12024. Epub 2013 Feb 25.
PubMed 23438101Parra D, Ramel A, Bandarra N, Kiely M, Martinez JA, Thorsdottir I. A diet rich in long chain omega-3 fatty acids modulates satiety in overweight and obese volunteers during weight loss. Appetite. 2008 Nov;51(3):676-80. doi: 10.1016/j.appet.2008.06.003. Epub 2008 Jun 14.
PubMed 18602429
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Pharmacologic Alternatives for the Treatment of Childhood Obesity in Mexico
- ClinicalTrials.gov ID
- NCT03670875
- Acronym / sponsor ID
- R-2016-785-103
- Conditions
- Obesity in Childhood
- Keywords
- Children, obesity, agave-inulin, curcumin, O3FA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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.
Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Animal models and clinical trials in adults have provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin, and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological alternatives could support diet and exercise to decrease the weight of children with obesity.
Detailed description
The aim of this study is to determinate the efficacy and safety of agave inulin, curcumin, and omega-3 fatty acids (O3FA) to decrease the weight of children with obesity.
Design. Randomized controlled clinical trial (RCT) with four study groups: agave inulin, curcumin, omega-3 fatty acids and a control group. All groups will receive instructions to decrease calories intake and do exercise.
Children sent to the unit with a presumptive diagnosis of obesity will be considered as candidates to the RCT. Children accomplishing with inclusion/exclusion criteria will be randomized to one of the study groups.
Sample size was calculated using a statistical power of 80%, alpha value of 0.05. A 15 % of difference, in the mean of weight reduction, between control group and intervention groups was considered. The estimated sample size was 75 subjects for each group.
Weight, height, BMI, blood pressure, abdominal circumference and body fat percentage will be measured in months 0, 1, 2, and 3. In months 0 and 3 a fasting venous blood sample will be drawn to perform the following test: glucose, insulin, lipid profile and C- Reactive protein, aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Anthropometric measures, food intake recommendation and diaries of food consume will be performed by trained nutritionists. Recommendation about type of exercise and estimation of calories consumed will be performed by a physical education teacher.
The statistical analysis will performed by one to the investigators blinded to treatment groups. Numerical values will be expressed as mean ± standard deviation. Categorical variables will be expressed as proportions. The analysis will be preformed according with CONSORT group recommendations Differences between the groups were estimated using one-way ANOVA with Bonferroni post-hoc test for numerical parameters and χ 2 test for categorical variables. Intragroup differences will be assessed by paired Student t test (Mann-Whitney U test for skewed data). Statistical significance will be considered as a p value <0.05 and 95% confidence interval (CI). Statistical Package for the Social Sciences will be used for the analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Study groups. Agave inulin: 2.3 g twice a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise. Curcumin: 600 mg (turmeric 600 + black pepper 5 mg) by mouth daily during 3 months plus recommendations to decrease calories intake an do exercise. Omega-3 fatty acids 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise. Control group with no intervention. Recommendations to decrease calories intake an do exercise. Dietary recommendations to ingest 1600 calories per day Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
| Arm | Type | Receives |
|---|---|---|
| Agave inulin | Experimental | Dietary Supplement: Agave inulinAgave inulin 2.3 g, by mouth, every 12 hours for 3 months. Plus recommendations to decrease calories intake an do exercise. |
| Curcumin | Experimental | Dietary Supplement: CurcuminCurcumin 600 mg (turmeric 600 + black pepper 5 mg) by mouth, daily for 3 months. Plus recommendations to decrease calories intake an do exercise. |
| Omega 3 Fatty Acids | Experimental | Dietary Supplement: O3FAO3FA 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth, every 8 hours for 3 months. Plus recommendations to decrease calories intake an do exercise. |
| Control | Other | Behavioral: ControlRecommendations to decrease calories intake an do exercise. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gender: Boys and Girls
- Diagnosis of obesity (percentile ≥ 95% according to The Centers for Disease Control and Prevention growth charts)
- Informed consent of parents
- Informed assent of the participant
Key exclusion criteria (10 listed)
- Diabetes
- Thyroid disease
- Renal disease
- Hepatic disease
- Neoplasia disease
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 |
|---|---|---|
| Agave inulinWill be provided in dehydrated apple cubes | Dietary supplement | Agave inulin |
| CurcuminAlso: TurmericWill be provided in capsules | Dietary supplement | Curcumin |
| O3FAWill be provided in capsules | Dietary supplement | Omega 3 Fatty Acids |
| ControlDietary recommendations to ingest 1600 calories per day. Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day) | Behavioural | Control |
Primary outcome
Loosing weight
Time frame: Three months
Weight lost between basal and third month visits. Determined by a digital scale
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 28 Sep 2023.
- Background: PubMed 25797547Gluckman P, Nishtar S, Armstrong T. Ending childhood obesity: a multidimensional challenge. Lancet. 2015 Mar 21;385(9973):1048-50. doi: 10.1016/S0140-6736(15)60509-8. No abstract available.
- Background: PubMed 18582508Siro I, Kapolna E, Kapolna B, Lugasi A. Functional food. Product development, marketing and consumer acceptance--a review. Appetite. 2008 Nov;51(3):456-67. doi: 10.1016/j.appet.2008.05.060. Epub 2008 Jun 4.
- Background: PubMed 23811098Tomaschunas M, Zorb R, Fischer J, Kohn E, Hinrichs J, Busch-Stockfisch M. Changes in sensory properties and consumer acceptance of reduced fat pork Lyon-style and liver sausages containing inulin and citrus fiber as fat replacers. Meat Sci. 2013 Nov;95(3):629-40. doi: 10.1016/j.meatsci.2013.06.002. Epub 2013 Jun 10.
- Background: PubMed 17002459Mancilla-Margalli NA, Lopez MG. Water-soluble carbohydrates and fructan structure patterns from Agave and Dasylirion species. J Agric Food Chem. 2006 Oct 4;54(20):7832-9. doi: 10.1021/jf060354v.
- BackgroundGonzález-Herrera SM, Rutiaga-Quiñones OM, Aguilar CN, et al. Dehydrated Apple matrix supplemented with agave fructans, inulin and oligofructose. LWT Food Science and Technology. 2016;65:1059-1065.
- Background: PubMed 24687355Lopez-Velazquez G, Diaz-Garcia L, Anzo A, Parra-Ortiz M, Llamosas-Gallardo B, Ortiz-Hernandez AA, Mancilla-Ramirez J, Cruz-Rubio JM, Gutierrez-Castrellon P. Safety of a dual potential prebiotic system from Mexican agave "Metlin(R) and Metlos(R)", incorporated to an infant formula for term newborn babies: a randomized controlled trial. Rev Invest Clin. 2013 Nov-Dec;65(6):483-90.
- Background: PubMed 19462685Wang SL, Li Y, Wen Y, Chen YF, Na LX, Li ST, Sun CH. Curcumin, a potential inhibitor of up-regulation of TNF-alpha and IL-6 induced by palmitate in 3T3-L1 adipocytes through NF-kappaB and JNK pathway. Biomed Environ Sci. 2009 Feb;22(1):32-9. doi: 10.1016/S0895-3988(09)60019-2.
- Background: PubMed 23239418Sahebkar A. Why it is necessary to translate curcumin into clinical practice for the prevention and treatment of metabolic syndrome? Biofactors. 2013 Mar-Apr;39(2):197-208. doi: 10.1002/biof.1062. Epub 2012 Dec 13.
- Background: PubMed 11040400Ramirez-Bosca A, Soler A, Carrion MA, Diaz-Alperi J, Bernd A, Quintanilla C, Quintanilla Almagro E, Miquel J. An hydroalcoholic extract of curcuma longa lowers the apo B/apo A ratio. Implications for atherogenesis prevention. Mech Ageing Dev. 2000 Oct 20;119(1-2):41-7. doi: 10.1016/s0047-6374(00)00169-x.
- BackgroundNagwa I, Ragab S, Baky A, et al. Effect of Oral Curcumin Administration on Insulin Resistance, Serum Resistin and Fetuin-A in Obese Children: Randomized Placebo- Controlled study. Reser J of Pharm, Biol and Chem Sci 2014 5:887-96
- Background: PubMed 23059643Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d.
- Background: PubMed 14686961Huang XF, Xin X, McLennan P, Storlien L. Role of fat amount and type in ameliorating diet-induced obesity: insights at the level of hypothalamic arcuate nucleus leptin receptor, neuropeptide Y and pro-opiomelanocortin mRNA expression. Diabetes Obes Metab. 2004 Jan;6(1):35-44. doi: 10.1111/j.1463-1326.2004.00312.x.
- Individual participant dataSharing planned: No
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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.
Fernando Guerrero, PhD principal investigator
Instituto Mexicano del Seguro Social
Gerardo Martinez, PhD study director
Instituto Mexicano del Seguro Social
Luis E Simental, PhD study chair
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agave inulin, Curcumin and O3FA in people with Obesity in Childhood, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 4 inclusion and 10 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Loosing weight (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670875, which also lists 15 linked publications.
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 28 Sep 2023.