Obesity, ChildhoodNCT04319419
Milk Proteins and Micronutrient Supplementation in Obese Children
A study testing Supplement with micronutrients and Nutrition education in people with Obesity, Childhood, run by Universidad Autonoma de Queretaro.
Trial summary
Milk proteins and micronutrients could be beneficial in the prevention and treatment of obesity. The objective was to evaluate a supplement with milk proteins and multivitamins and minerals with nutrition education on anthropometry, body composition, micronutrient status, blood pressure, lipid profile, systemic… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Supplement with micronutrients and Nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2011to 5 Dec 2012
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with obesity (BMI>30)
- Aged: 6 to 11 years
- Both sex
- Parents accepted to participate and signed informant consent
Who cannot join
- Children with dyslipidemia
- Metabolic disease
- Hypertension
- Physical disability
- Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.
About this study
Official title: Effectiveness of a Supplement Containning Milk Proteins, Vitamins and Minerals to Reduce Fat Deposition, Systemic Inflammation and Improve Nutritional Status in Obese School-age Children
Milk proteins and micronutrients could be beneficial in the prevention and treatment of obesity.
The objective was to evaluate a supplement with milk proteins and multivitamins and minerals with nutrition education on anthropometry, body composition, micronutrient status, blood pressure, lipid profile, systemic inflammation, leptin and insulin resistance in obese children at baseline and after 6 months.
Read the detailed description
Obese children were selected in elementary schools from 5 rural communities of the State of Querétaro. One hundred fifty two obese children (Z-score >2 standard deviations) aged 6-11y were randomly assigned to receive one of two treatments: 1) 237mL/day of milk proteins and multiple micronutrients supplement (MPMS) plus Nutrition Education (NE) program or 2) NE alone for 24 weeks.
Children in both groups were evaluated at baseline and 6 months after treatment initiated. At both times the following variables were evaluated:
Visit 1 (Screening): Mothers and parents received oral and written information regarding all aspects of the study. Informed consent, medical history, demographic information, weight and height were obtained.
Visit 2 (Clinical Laboratory testing): A blood preasure and sample was taken by an specialist. Blood test included Glucose, total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol, Tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6) and interleukin-10 (IL-10), C reactive protein, insulin and leptin.
Visit 3 (Nutrition Clinic at UAQ): body composition was determined by DEXA. The NE were given at Nutrition Clinic and school to the children's parents each week.
- Conditions
- Obesity, Childhood
- Being tested
- Supplement with micronutrients, Nutrition education
- Keywords
- micronutrients, obesity, school-age children, milk proteins
- 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.
Supplement with micronutrientsDietary supplement
Obese children were divided in 2 groups. A group received the supplement plus nutrition education and other group was a control, only received nutrition education.
Nutrition educationOther
Group received nutrition education program during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Supplement with micronutrients | Experimental | Nutrition education with a supplement Receives: Dietary Supplement: Supplement with micronutrients |
| Nutrition education | Experimental | Group received only nutrition education Receives: Other: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat
change in fat
Measured: baseline to 6 months
Secondary outcomes (18)
Total cholesterol
Change in total cholesterol
Measured: Beaseline to 6 months
HDL
change in HDL
Measured: Baseline to 6 months
LDL
change in LDL
Measured: baseline to 6 months
Triglycerides
change in triglycerides
Measured: baseline to 6 months
Glucose
change in glucose
Measured: baseline to 6 months
Interleukin 6 (IL-6)
Change in IL-6
Measured: baseline to 6 months
Interleukin 10 (IL-10)
change of IL-10 change in IL-10
Measured: baseline to 6 months
C reactive protein (CRP)
change of CRP
Measured: baseline to 6 months
Bone mineral density (BMD)
change in BMD
Measured: baseline to 6 months
Body mass index (BMI)
Change in BMI
Measured: Baseline to 6 months
Zinc levels
Change in zinc levels
Measured: baseline to 6 months
Iron levels
Change in iron levels
Measured: baseline to 6 months
A vitamin levels
change in A vitamin levels
Measured: baseline to 6 months
C vitamin levels
change of C vitamin levels
Measured: baseline to 6 months
D vitamin levels
change in D vitamin levels
Measured: baseline to 6 months
E vitamin levels
change of E vitamin levels
Measured: baseline to 6 months
Systolic blood pressure (SBP)
change in SBP
Measured: baseline to 6 months
Diastolic blood pressure (DBP)
change in (DBP)
Measured: baseline 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 posted24 Mar 2020
- Study start5 Dec 2011
- Primary completion5 Dec 2012
- Study completion5 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, 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
- Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Collaborators
- NUCITEC S.A. de C.V.
- Responsible party
- Principal investigator, Jorge Luis Rosado Loria, Universidad Autonoma de Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319419
- Sponsor's protocol ID
- FNN201104
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Supplement Containning Milk Proteins, Vitamins and Minerals to Reduce Fat Deposition, Systemic Inflammation and Improve Nutritional Status in Obese School-age Children
- ClinicalTrials.gov ID
- NCT04319419
- Acronym / sponsor ID
- FNN201104
- Conditions
- Obesity, Childhood
- Keywords
- micronutrients, obesity, school-age children, milk proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Collaborators
- NUCITEC S.A. de C.V.
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 5 Dec 2012 (actual)
- Study completion
- 5 Dec 2012 (actual)
- First posted
- 24 Mar 2020 (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.
Milk proteins and micronutrients could be beneficial in the prevention and treatment of obesity.
The objective was to evaluate a supplement with milk proteins and multivitamins and minerals with nutrition education on anthropometry, body composition, micronutrient status, blood pressure, lipid profile, systemic inflammation, leptin and insulin resistance in obese children at baseline and after 6 months.
Detailed description
Obese children were selected in elementary schools from 5 rural communities of the State of Querétaro. One hundred fifty two obese children (Z-score >2 standard deviations) aged 6-11y were randomly assigned to receive one of two treatments: 1) 237mL/day of milk proteins and multiple micronutrients supplement (MPMS) plus Nutrition Education (NE) program or 2) NE alone for 24 weeks.
Children in both groups were evaluated at baseline and 6 months after treatment initiated. At both times the following variables were evaluated:
Visit 1 (Screening): Mothers and parents received oral and written information regarding all aspects of the study. Informed consent, medical history, demographic information, weight and height were obtained.
Visit 2 (Clinical Laboratory testing): A blood preasure and sample was taken by an specialist. Blood test included Glucose, total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol, Tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6) and interleukin-10 (IL-10), C reactive protein, insulin and leptin.
Visit 3 (Nutrition Clinic at UAQ): body composition was determined by DEXA. The NE were given at Nutrition Clinic and school to the children's parents each week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group received only nutrition education and treated group received nutrition education plus a supplement with milk protein and micronutrients.
| Arm | Type | Receives |
|---|---|---|
| Supplement with micronutrients | Experimental | Dietary Supplement: Supplement with micronutrientsNutrition education with a supplement |
| Nutrition education | Experimental | Other: Nutrition educationGroup received only nutrition education |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with obesity (BMI>30)
- Aged: 6 to 11 years
- Both sex
- Parents accepted to participate and signed informant consent
Key exclusion criteria (5 listed)
- Children with dyslipidemia
- Metabolic disease
- Hypertension
- Physical disability
- Using vitamins and minerals supplements and/or receiving treatment for obesity during the last 3 months.
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 |
|---|---|---|
| Supplement with micronutrientsObese children were divided in 2 groups. A group received the supplement plus nutrition education and other group was a control, only received nutrition education. | Dietary supplement | Supplement with micronutrients |
| Nutrition educationGroup received nutrition education program during 6 months | Other | Nutrition education |
Primary outcome
Total body fat
Time frame: baseline to 6 months
change in fat
18 secondary outcomes
Total cholesterol
Time frame: Beaseline to 6 months
HDL
Time frame: Baseline to 6 months
LDL
Time frame: baseline to 6 months
Triglycerides
Time frame: baseline to 6 months
Glucose
Time frame: baseline to 6 months
Interleukin 6 (IL-6)
Time frame: baseline to 6 months
Interleukin 10 (IL-10)
Time frame: baseline to 6 months
C reactive protein (CRP)
Time frame: baseline to 6 months
Bone mineral density (BMD)
Time frame: baseline to 6 months
Body mass index (BMI)
Time frame: Baseline to 6 months
Zinc levels
Time frame: baseline to 6 months
Iron levels
Time frame: baseline to 6 months
A vitamin levels
Time frame: baseline to 6 months
C vitamin levels
Time frame: baseline to 6 months
D vitamin levels
Time frame: baseline to 6 months
E vitamin levels
Time frame: baseline to 6 months
Systolic blood pressure (SBP)
Time frame: baseline to 6 months
Diastolic blood pressure (DBP)
Time frame: baseline 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 24 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement with micronutrients and Nutrition education in people with Obesity, Childhood, run by Universidad Autonoma de Queretaro.
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 5 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 24 Mar 2020. 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. 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?
Total body fat (time frame: baseline to 6 months). 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 24 Mar 2020.