Child ObesityPUFANCT05488223
Supplementation With PUFA´s in Obese Children
A study testing AGPI ω-3 (Triple Strength Fish Oil®), AGPI ω-3 + MUFA (avocado oil) and MUFA (avocado oil) (1.8g) in people with Child Obesity and Insulin Resistance, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
Introduction. Insulin resistance (IR) accompanies practically half of children with obesity. This alteration is the border between what can be reversible or permanent. Among the comorbidities associated with IR are T2D and cardio and cerebrovascular diseases, which are the leading causes of death in Mexico. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Obesity, Insulin Resistance, Metabolic Complication
- What is being tested?
- AGPI ω-3 (Triple Strength Fish Oil®), AGPI ω-3 + MUFA (avocado oil) and MUFA (avocado oil) (1.8g)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteMexico
- Study dates
- 17 Feb 2014to 26 Sep 2016
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with obesity (BMI ≥95 pc), according to the CDC reference tables.
- HOMA-IR ≥ 3.0.
- That they grant their written consent to participate.
Who cannot join
- Patients with any chronic disease.
- Patients who consume medications that alter their metabolic profile.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Omega 3 Polyunsaturated Fatty Acid Schemes on Insulin Resistance and the Inflammatory and Lipid Profile in Obese Children
Introduction. Insulin resistance (IR) accompanies practically half of children with obesity. This alteration is the border between what can be reversible or permanent. Among the comorbidities associated with IR are T2D and cardio and cerebrovascular diseases, which are the leading causes of death in Mexico. It has been said that the prevention of obesity rather than its treatment is the way to contain this problem. It has been proposed to supplement obese children with IR with ω-3 polyunsaturated fatty acids (PUFA) or ω-9 monounsaturated fatty acids (MUFA) to determine their ability to reverse these alterations.
Objetive. To evaluate the effect of supplementing PUFA ω-3, PUFA ω-9 or both, on the change in anthropometric and metabolic parameters in obese children with IR.
Methods. Clinical trial, randomized triple-blind, in which obese children with IR participated. Intervention. Three groups were integrated that received one of the following treatments for three months: Group 1: PUFA ω-3 1.8 g/day; Group 2: PUFA ω-3 0.9 g/day + PUFA ω-9 0.9 g/day (avocado oil). Group 3: MUFA ω-9 1.8 g/day. Tracing. For 2 more months he continued his clinical surveillance. Anthropometric and metabolic profile measurements were made at baseline, 3 and 5 months. Throughout the study, all three child groups received nutritional counseling, but no calorie-restricted diets or exercise programs were used.
Read the detailed description
Specific objectives
- To compare between the study groups, the concentrations of glucose, insulin and HOMA-IR Index, at baseline, at the end of supplementation with PUFA ω-3 and PUFA ω-9 (3 months) and 2 months after supplementation. the supplementation.
- To compare between the study groups, the concentrations of total cholesterol, HDL cholesterol, LDL cholesterol and TG at baseline, at the end of supplementation and 2 months after supplementation.
- To compare between the study groups the change in the percentile values of body mass index (BMI) and waist circumference (WC), between the study groups, at baseline, at the end of supplementation (3 months) and 2 months after supplementation.
Methods. A randomized, controlled, triple-blind clinical trial was conducted, which included 133 children with obesity (BMI ≥95th percentile) and with IR (HOMA-IR ≥ 3.0).
- Conditions
- Child Obesity, Insulin Resistance, Metabolic Complication
- Being tested
- AGPI ω-3 (Triple Strength Fish Oil®), AGPI ω-3 + MUFA (avocado oil), MUFA (avocado oil) (1.8g)
- Keywords
- child, obesity, insulin resistance, metabolic profile, PUFA ω-3
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGPI ω-3 (Triple Strength Fish Oil®)Dietary supplement
The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.
AGPI ω-3 + MUFA (avocado oil)Dietary supplement
AGPI ω-3 (0.9g) + MUFA (avocado oil) (0.9g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.
MUFA (avocado oil) (1.8g)Dietary supplement
MUFA (avocado oil) (1.8g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.
| Study group | Role | What they receive |
|---|---|---|
| PUFA ω-3 (1.8g/day) | Experimental | ω-3 PUFAs (Triple Strength Fish Oil®) were purchased in advance, each capsule contained 540 mg of eicosapentaenoic acid (20:5 n-3) and 360 mg of docosahexaenoic acid (22:6 n-3), for a 0.9g total. Children and parents were told that they should take 2 capsules of ω-3 PUFAs daily, that is, they took 1.8g/day.
Parents and children were informed that the duration of the study would be 5 months, in the first three months, the children should take the capsules of the assigned treatment; in the fourth and fifth months they should continue their surveillance with the researchers. At the beginning, they were given 2 bottles of 30 capsules each, identified as formula A or B, according to the assigned group, and they were given a calendar sheet indicating that they should cross out a box if they had consumed the breakfast capsule and cross out another box if the consumed during the meal; Likewise, they were asked to write down any adverse effect, if any, on the same sheet. Receives: Dietary Supplement: AGPI ω-3 (Triple Strength Fish Oil®) |
| PUFAs ω-3 0.9 g/day + MUFAs (avocado oil) 0.9 g/day. | Active comparator | A commercial brand of avocado oil (MUFA) was purchased in advance by putting 0.9g in each capsule. The appearance of the ω-3 PUFA capsules and the avocado oil capsules were the same. Then we worked with the company that prepared the blinding of the treatments, packaging bottles of 30 capsules each, labeling them as bottles A and B. The design contemplated giving each child two bottles, one marked to take it for breakfast and another marked to take it with food. The child was instructed to take 1 capsule per day of PUFA ω-3 (0.9g/d) and 1 capsule of avocado oil (0.9g/d) Receives: Dietary Supplement: AGPI ω-3 + MUFA (avocado oil) |
| MUFAs (avocado oil) 1.8 g/day. | Placebo comparator | The child was instructed to take 2 capsules per day, 1.8g of avocado oil per day. Receives: Dietary Supplement: MUFA (avocado oil) (1.8g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance
Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software.
The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (μU/ml) / 405
Measured: Change in insulin resistance from baseline at 3 months
Change in insulin resistance
Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software.
The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (μU/ml) / 405
Measured: Change in insulin resistance from baseline at 5 months
Change in BMI percentile
Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.
Measured: Change in BMI percentile from baseline at 3 months
Change in BMI percentile
Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.
Measured: Change in BMI percentile from baseline at 5 months
Secondary outcomes (6)
Change in waist circumference (percentile)
Waist circumference (cm) was measured with the children in a standing position, using a flexible tape measure (Seca 201®), placed at the midpoint between the lower rib and the iliac crest after a normal exhalation, according to the protocol of WHO. Using the tables of waist circumference of Mexican children, a very high risk was considered if the circumference was greater than the 90th percentile
Measured: Change in waist circumference percentile from baseline at 3 months
Change in waist circumference (percentile)
Waist circumference (cm) was measured with the children in a standing position, using a flexible tape measure (Seca 201®), placed at the midpoint between the lower rib and the iliac crest after a normal exhalation, according to the protocol of WHO. Using the tables of waist circumference of Mexican children, a very high risk was considered if the circumference was greater than the 90th percentile.
Measured: Change in waist circumference percentile from baseline at 5 months
Change in metabolic parameters (mg/dL)
Glucose (mg/dL), low-density lipoprotein (mg/dL), high-density lipoprotein (mg/dL), triglycerides (mg/dL), and total cholesterol (mg/dL) determinations were analyzed with enzymatic methods according to the procedures manual of the Central Laboratory of the Hospital Infantil de México Federico Gómez (Dimension-RXL, Dade Behring, Germany).
Measured: Change in metabolic parameters (mg/dL)from baseline at 3 months
Change in metabolic parameters (mg/dL)
Glucose (mg/dL), low-density lipoprotein (mg/dL), high-density lipoprotein (mg/dL), triglycerides (mg/dL), and total cholesterol (mg/dL) determinations were analyzed with enzymatic methods according to the procedures manual of the Central Laboratory of the Hospital Infantil de México Federico Gómez (Dimension-RXL, Dade Behring, Germany).
Measured: Change in metabolic parameters (mg/dL) from baseline at 5 months
Change in cytokines (pg/mL)
In serum, the following cytokines IL1B, IL4, IL_6, IL10, IFNg, MCP1, TNTa and Leptin (pg/mL) are determined. Based on automated Luminex xMAP® technology.
Measured: Change in cytokines (pg/mL) from baseline at 3 months
Change in cytokines (pg/mL)
In serum, the following cytokines IL1B, IL4, IL_6, IL10, IFNg, MCP1, TNTa and Leptin (pg/mL) are determined. Based on automated Luminex xMAP® technology.
Measured: Change in cytokines (pg/mL) from baseline at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start17 Feb 2014
- Primary completion16 Dec 2015
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Subject to written informed consent, children who agreed to participate were randomly assigned to the following treatment groups. Group 1. Two daily capsules of ω-3FAs; Group 2. Two daily capsules, one of ω-3FAs of 0.9 g + 1 capsule of avocado oil (AcAg) of 0.9 g and; Group 3. Two daily capsules of 0.9 g of AcAg.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario del Sur, Guadalajara, Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche
- Responsible party
- Principal investigator, Jenny Vilchis Gil, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Jenny Vilchis Gil, PhD, Principal investigator, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488223
- Sponsor's protocol ID
- HIM/2013/0001
- Acronym
- PUFA
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared once the statistical analyzes are carried out and it is sent for publication.
Publications
Juarez-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 23438101Juarez-Lopez C, Klunder-Klunder M, Medina-Bravo P, Madrigal-Azcarate A, Mass-Diaz E, Flores-Huerta S. Insulin resistance and its association with the components of the metabolic syndrome among obese children and adolescents. BMC Public Health. 2010 Jun 7;10:318. doi: 10.1186/1471-2458-10-318.
PubMed 20529295Vilchis-Gil J, Galvan-Portillo M, Klunder-Klunder M, Cruz M, Flores-Huerta S. Food habits, physical activities and sedentary lifestyles of eutrophic and obese school children: a case-control study. BMC Public Health. 2015 Feb 11;15:124. doi: 10.1186/s12889-015-1491-1.
PubMed 25885348
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Omega 3 Polyunsaturated Fatty Acid Schemes on Insulin Resistance and the Inflammatory and Lipid Profile in Obese Children
- ClinicalTrials.gov ID
- NCT05488223
- Acronym / sponsor ID
- PUFA / HIM/2013/0001
- Conditions
- Child Obesity, Insulin Resistance, Metabolic Complication
- Keywords
- child, obesity, insulin resistance, metabolic profile, PUFA ω-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Collaborators
- Centro Universitario del Sur, Guadalajara, Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche
- Study start
- 17 Feb 2014 (actual)
- Primary completion
- 16 Dec 2015 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 4 Aug 2022 (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.
Introduction. Insulin resistance (IR) accompanies practically half of children with obesity. This alteration is the border between what can be reversible or permanent. Among the comorbidities associated with IR are T2D and cardio and cerebrovascular diseases, which are the leading causes of death in Mexico. It has been said that the prevention of obesity rather than its treatment is the way to contain this problem. It has been proposed to supplement obese children with IR with ω-3 polyunsaturated fatty acids (PUFA) or ω-9 monounsaturated fatty acids (MUFA) to determine their ability to reverse these alterations.
Objetive. To evaluate the effect of supplementing PUFA ω-3, PUFA ω-9 or both, on the change in anthropometric and metabolic parameters in obese children with IR.
Methods. Clinical trial, randomized triple-blind, in which obese children with IR participated. Intervention. Three groups were integrated that received one of the following treatments for three months: Group 1: PUFA ω-3 1.8 g/day; Group 2: PUFA ω-3 0.9 g/day + PUFA ω-9 0.9 g/day (avocado oil). Group 3: MUFA ω-9 1.8 g/day. Tracing. For 2 more months he continued his clinical surveillance. Anthropometric and metabolic profile measurements were made at baseline, 3 and 5 months. Throughout the study, all three child groups received nutritional counseling, but no calorie-restricted diets or exercise programs were used.
Detailed description
Specific objectives
- To compare between the study groups, the concentrations of glucose, insulin and HOMA-IR Index, at baseline, at the end of supplementation with PUFA ω-3 and PUFA ω-9 (3 months) and 2 months after supplementation. the supplementation.
- To compare between the study groups, the concentrations of total cholesterol, HDL cholesterol, LDL cholesterol and TG at baseline, at the end of supplementation and 2 months after supplementation.
- To compare between the study groups the change in the percentile values of body mass index (BMI) and waist circumference (WC), between the study groups, at baseline, at the end of supplementation (3 months) and 2 months after supplementation.
Methods. A randomized, controlled, triple-blind clinical trial was conducted, which included 133 children with obesity (BMI ≥95th percentile) and with IR (HOMA-IR ≥ 3.0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Subject to written informed consent, children who agreed to participate were randomly assigned to the following treatment groups. Group 1. Two daily capsules of ω-3FAs; Group 2. Two daily capsules, one of ω-3FAs of 0.9 g + 1 capsule of avocado oil (AcAg) of 0.9 g and; Group 3. Two daily capsules of 0.9 g of AcAg.
| Arm | Type | Receives |
|---|---|---|
| PUFA ω-3 (1.8g/day) | Experimental | Dietary Supplement: AGPI ω-3 (Triple Strength Fish Oil®)ω-3 PUFAs (Triple Strength Fish Oil®) were purchased in advance, each capsule contained 540 mg of eicosapentaenoic acid (20:5 n-3) and 360 mg of docosahexaenoic acid (22:6 n-3), for a 0.9g total. Children and parents were told that they should take 2 capsules of ω-3 PUFAs daily, that is, they took 1.8g/day. Parents and children were informed that the duration of the study would be 5 months, in the first three months, the children should take the capsules of the assigned treatment; in the fourth and fifth months they should continue their surveillance with the researchers. At the beginning, they were given 2 bottles of 30 capsules each, identified as formula A or B, according to the assigned group, and they were given a calendar sheet indicating that they should cross out a box if they had consumed the breakfast capsule and cross out another box if the consumed during the meal; Likewise, they were asked to write down any adverse effect, if any, on the same sheet. |
| PUFAs ω-3 0.9 g/day + MUFAs (avocado oil) 0.9 g/day. | Active comparator | Dietary Supplement: AGPI ω-3 + MUFA (avocado oil)A commercial brand of avocado oil (MUFA) was purchased in advance by putting 0.9g in each capsule. The appearance of the ω-3 PUFA capsules and the avocado oil capsules were the same. Then we worked with the company that prepared the blinding of the treatments, packaging bottles of 30 capsules each, labeling them as bottles A and B. The design contemplated giving each child two bottles, one marked to take it for breakfast and another marked to take it with food. The child was instructed to take 1 capsule per day of PUFA ω-3 (0.9g/d) and 1 capsule of avocado oil (0.9g/d) |
| MUFAs (avocado oil) 1.8 g/day. | Placebo comparator | Dietary Supplement: MUFA (avocado oil) (1.8g)The child was instructed to take 2 capsules per day, 1.8g of avocado oil per day. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with obesity (BMI ≥95 pc), according to the CDC reference tables.
- HOMA-IR ≥ 3.0.
- That they grant their written consent to participate.
Key exclusion criteria (2 listed)
- Patients with any chronic disease.
- Patients who consume medications that alter their metabolic profile.
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 |
|---|---|---|
| AGPI ω-3 (Triple Strength Fish Oil®)The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs. | Dietary supplement | PUFA ω-3 (1.8g/day) |
| AGPI ω-3 + MUFA (avocado oil)AGPI ω-3 (0.9g) + MUFA (avocado oil) (0.9g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs. | Dietary supplement | PUFAs ω-3 0.9 g/day + MUFAs (avocado oil) 0.9 g/day. |
| MUFA (avocado oil) (1.8g)MUFA (avocado oil) (1.8g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs. | Dietary supplement | MUFAs (avocado oil) 1.8 g/day. |
Primary outcome
Change in insulin resistance
Time frame: Change in insulin resistance from baseline at 3 months
Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software. The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (μU/ml) / 405
Change in insulin resistance
Time frame: Change in insulin resistance from baseline at 5 months
Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software. The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (μU/ml) / 405
Change in BMI percentile
Time frame: Change in BMI percentile from baseline at 3 months
Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.
Change in BMI percentile
Time frame: Change in BMI percentile from baseline at 5 months
Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.
6 secondary outcomes
Change in waist circumference (percentile)
Time frame: Change in waist circumference percentile from baseline at 3 months
Change in waist circumference (percentile)
Time frame: Change in waist circumference percentile from baseline at 5 months
Change in metabolic parameters (mg/dL)
Time frame: Change in metabolic parameters (mg/dL)from baseline at 3 months
Change in metabolic parameters (mg/dL)
Time frame: Change in metabolic parameters (mg/dL) from baseline at 5 months
Change in cytokines (pg/mL)
Time frame: Change in cytokines (pg/mL) from baseline at 3 months
Change in cytokines (pg/mL)
Time frame: Change in cytokines (pg/mL) from baseline at 5 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 4 Aug 2022.
- Results publication: PubMed 23438101Juarez-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.
- Results publication: PubMed 20529295Juarez-Lopez C, Klunder-Klunder M, Medina-Bravo P, Madrigal-Azcarate A, Mass-Diaz E, Flores-Huerta S. Insulin resistance and its association with the components of the metabolic syndrome among obese children and adolescents. BMC Public Health. 2010 Jun 7;10:318. doi: 10.1186/1471-2458-10-318.
- Results publication: PubMed 25885348Vilchis-Gil J, Galvan-Portillo M, Klunder-Klunder M, Cruz M, Flores-Huerta S. Food habits, physical activities and sedentary lifestyles of eutrophic and obese school children: a case-control study. BMC Public Health. 2015 Feb 11;15:124. doi: 10.1186/s12889-015-1491-1.
- This page is from the Hospital Infantil de México Federico Gómez where the research protocol was approved and developed.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be shared once the statistical analyzes are carried out and it is sent for publication.
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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.
Jenny Vilchis Gil, PhD principal investigator
Hospital Infantil de Mexico Federico Gomez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGPI ω-3 (Triple Strength Fish Oil®), AGPI ω-3 + MUFA (avocado oil) and MUFA (avocado oil) (1.8g) in people with Child Obesity and Insulin Resistance, run by Hospital Infantil de Mexico Federico Gomez 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 3 inclusion and 2 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 4 Aug 2022. 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. 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.
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 insulin resistance (time frame: Change in insulin resistance from baseline at 3 months). The study lists 4 primary outcomes in all. 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 NCT05488223, which also lists 3 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 4 Aug 2022.