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Mediterranean Enriched Diet for Tackling Youth Obesity (MED4Youth)

Primary Purpose

Obesity, Adolescent, Lifestyle, Healthy, Diet, Healthy

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diet and behavioural intervention
Diet and behavioural intervention
Sponsored by
Fundació Eurecat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Adolescent focused on measuring Youth Obesity, Mediterranean diet, Interventional study, Healthy lifestyles, Educational approach

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • boys and girls aged 13-17 years
  • having obesity, defined as an age- and sex-specific BMI in the 95th percentile or greater (1), or great overweight (age- and sex-specific BMI in the ≥90th to <95th percentile),
  • having informed consent (sign by both, one parent and the adolescent),
  • and to have a mobile phone with internet access.

Exclusion Criteria:

  • having diabetes and other metabolic, endocrine and chronic disorders;
  • intake of antibiotics, drug, probiotics or nutritional supplements in the last month;
  • prescribed medicine to control hypertension, inflammation or dyslipidemia,
  • following a prescribed diet for any reason, including weight loss, in the last 3 months;
  • following a religion-restricted diet;
  • and having allergies or food intolerances in: nuts, pomegranate, bread and/or chickpeas.

Sites / Locations

  • Eurecat

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean diet group

Low-fat diet group

Arm Description

1) The MD will be based on high consumption of unsaturated fat from vegetable sources (virgin olive oil and nuts) and minimally processed plant foods (vegetables, fruits, nuts, whole grains and legumes), low consumption of meat (especially red and processed meats) and sweets, and moderate consumption of fish and dairy products (mainly yoghurt and cheese). Accordingly, this diet will provide a high amount of mono and polyunsaturated fatty acids, fibre and phenolic compounds. Adolescents in the MD group will replace the intake of conventional breads by sourdough bread consumption (2 servings of 50-60 g daily) and incorporate into their diet chickpeas (2 servings of 150 g/week chickpeas, minimum one of them in hummus format), and they will consume at least another serving of legumes which can be chickpeas or another legume), pomegranate juice (4 servings of 200ml/week) and mixed nuts (4 servings of 30 g/week).

2) The low-fat diet (control diet) will be based on low consumption of fats. A low-fat diet is the most used diet for obesity treatment in adolescents. This group will not receive any additional specific food by researchers. This diet will be based on the diet proposed as low-fat diet in the PREDIMED study

Outcomes

Primary Outcome Measures

Change from baseline BMI z-score at 4 months and 8 months
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.

Secondary Outcome Measures

Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
Change of Adherence to the Mediterranean Diet using KIDMED test by comparing control between the intervention group Scores: =<3 points: Very low-quality diet 4 to 7 points: Need to improve the eating pattern to fit the model Mediterranean. =>8 points: Optimal Mediterranean diet
Change from baseline Level of physical activity at 4 and 8 months
Change of Physical Activity using the Physical Activity Questionnaire test by comparing control between the intervention group A score 1 indicates low physical activity whereas a score of 5 indicates high physical activity
Change from baseline Habit/food intake at 4 and 8 months
Change of Habit/food intake using 3-day dietary record, Helena study food frequency questionnaire by comparing control between intervention group
Change from baseline Knowledge about food and nutrition intake at 4 and 8 months
Change of Knowledge about food and nutrition intake using Helena's study knowledge questionnaire by comparing control between intervention group
Change from baseline Life quality at 4 and 8 months
Change of life quality using kidscreen-27 Index by comparing control between intervention group
Sociodemographic data of the parents one time frame
Sociodemographic data of the parents will be assessed at baseline of study using Healthy Behaviour in School Age Children. Sociodemographic data will be divided by low, medium or high socioeconomic level.
Change from baseline BMI data at 4 and 8 months
BMI will be assessed by weight (kg) / height (m2), and using Centers for Disease Control and Prevention (CDC) BMI percentiles and will be compared between control and intervention group.
Change from baseline waist circumference data at 4 and 8 months
Waist circumference (cm) will be evaluated and will be compared between control and intervention group.
Change from baseline Waist-hip ratio data at 4 and 8 months
Waist-hip ratio will be evaluated by waist and hip circumference and will be compared between control and intervention group.
Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)
Gut-derived metabolites of both groups will be evaluated by Faeces and/or plasma using NMR /GC-MS
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Biomarkers of oxidative stres of both groups will be evaluated by urine using ELISA
Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)
Biomarkers of inflammation of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)
Biomarkers of adipose tissue function of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Change of Biomarkers of insulin resistance
Biomarkers of insulin resistance of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Change of biomarkers of cardiovascular risk (TMAO)
Biomarkers of cardiovascular risk of both groups will be evaluated by plasma and urine using UHPLC MS
Change of circulating levels of glucose and blood lipid profile
Circulating levels of glucose and blood lipid profile of both groups will be evaluated using Enzymatic assays
Change of Food Intake biomarkers
Food Intake biomarkers of both groups will be evaluated by urine using Metabolomics (UHPLC MS)
Change of Advanced glycation end products (AGEs) related analyses
Advanced glycation end products will be assessed by plasma or erythrocytes using ELISA / enzymatic assays

Full Information

First Posted
January 14, 2021
Last Updated
July 31, 2023
Sponsor
Fundació Eurecat
Collaborators
University of Parma, University of Coimbra, Hospital Universitari Sant Joan de Reus
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1. Study Identification

Unique Protocol Identification Number
NCT04719052
Brief Title
Mediterranean Enriched Diet for Tackling Youth Obesity
Acronym
MED4Youth
Official Title
Mediterranean Enriched Diet for Tackling Youth Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Eurecat
Collaborators
University of Parma, University of Coimbra, Hospital Universitari Sant Joan de Reus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours. It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ≥90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021. The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ≥95 percentile (obesity) and a caloric restriction <20% of the total energy requirements will be applied in adolescents with BMI ≥90 to <95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.
Detailed Description
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups. The secondary outcomes are: Adherence to the DM, KidMed questionnaire; Level of physical activity, PAQ-A questionnaire; Habit/food intake: 3-day dietary record, Helena study food frequency questionnaire, Knowledge about food and nutrition, a questionnaire from Helena's study; Quality of life, kid screen-27 Index; Sociodemographic data of the parents; Anthropometric data: weight, height, BMI, body composition, waist circumference, waist-hip ratio; Clinical variables: blood pressure, Biochemical variables and omic determinations: in urine, blood and feces. In total, the adolescents will receive 5 visits: 1 pre-selection visit (to check inclusion / exclusion criteria in the study) (V0) 1 inclusion visit (V1) in which stool, urine, and blood samples will be collected, anthropometric measurements (such as weight and waist circumference) and blood pressure will be taken, and questionnaires and records will be answered dietary. 1 follow-up visit (V2), at 2 months, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered. 1 final visit (V3), at 4 months, in which stool, urine, and blood samples will be collected, anthropometric and blood pressure measurements will be made, and questionnaires and dietary records will be answered. 1 post-intervention follow-up visit (V4), 4 months after the end of the intervention, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Lifestyle, Healthy, Diet, Healthy, Cardiovascular Risk Factor
Keywords
Youth Obesity, Mediterranean diet, Interventional study, Healthy lifestyles, Educational approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicentre, blind, single-randomized, parallel, clinical trial
Masking
Investigator
Masking Description
Due to the nature of the study, the participants cannot be blinded to the intervention, although the investigators who will perform the sample and data analysis will be blinded.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean diet group
Arm Type
Experimental
Arm Description
1) The MD will be based on high consumption of unsaturated fat from vegetable sources (virgin olive oil and nuts) and minimally processed plant foods (vegetables, fruits, nuts, whole grains and legumes), low consumption of meat (especially red and processed meats) and sweets, and moderate consumption of fish and dairy products (mainly yoghurt and cheese). Accordingly, this diet will provide a high amount of mono and polyunsaturated fatty acids, fibre and phenolic compounds. Adolescents in the MD group will replace the intake of conventional breads by sourdough bread consumption (2 servings of 50-60 g daily) and incorporate into their diet chickpeas (2 servings of 150 g/week chickpeas, minimum one of them in hummus format), and they will consume at least another serving of legumes which can be chickpeas or another legume), pomegranate juice (4 servings of 200ml/week) and mixed nuts (4 servings of 30 g/week).
Arm Title
Low-fat diet group
Arm Type
Active Comparator
Arm Description
2) The low-fat diet (control diet) will be based on low consumption of fats. A low-fat diet is the most used diet for obesity treatment in adolescents. This group will not receive any additional specific food by researchers. This diet will be based on the diet proposed as low-fat diet in the PREDIMED study
Intervention Type
Other
Intervention Name(s)
Diet and behavioural intervention
Other Intervention Name(s)
MEDITERRANEAN DIET
Intervention Description
Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet
Intervention Type
Other
Intervention Name(s)
Diet and behavioural intervention
Other Intervention Name(s)
LOW-FAT DIET
Intervention Description
Control group will receive a specific diet designed following the characteristics of Low fat Diet.
Primary Outcome Measure Information:
Title
Change from baseline BMI z-score at 4 months and 8 months
Description
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups.
Time Frame
"4 months" and "4 months after study cessation"
Secondary Outcome Measure Information:
Title
Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
Description
Change of Adherence to the Mediterranean Diet using KIDMED test by comparing control between the intervention group Scores: =<3 points: Very low-quality diet 4 to 7 points: Need to improve the eating pattern to fit the model Mediterranean. =>8 points: Optimal Mediterranean diet
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline Level of physical activity at 4 and 8 months
Description
Change of Physical Activity using the Physical Activity Questionnaire test by comparing control between the intervention group A score 1 indicates low physical activity whereas a score of 5 indicates high physical activity
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline Habit/food intake at 4 and 8 months
Description
Change of Habit/food intake using 3-day dietary record, Helena study food frequency questionnaire by comparing control between intervention group
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline Knowledge about food and nutrition intake at 4 and 8 months
Description
Change of Knowledge about food and nutrition intake using Helena's study knowledge questionnaire by comparing control between intervention group
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline Life quality at 4 and 8 months
Description
Change of life quality using kidscreen-27 Index by comparing control between intervention group
Time Frame
"4 months" and "4 months after study cessation"
Title
Sociodemographic data of the parents one time frame
Description
Sociodemographic data of the parents will be assessed at baseline of study using Healthy Behaviour in School Age Children. Sociodemographic data will be divided by low, medium or high socioeconomic level.
Time Frame
1 time frame
Title
Change from baseline BMI data at 4 and 8 months
Description
BMI will be assessed by weight (kg) / height (m2), and using Centers for Disease Control and Prevention (CDC) BMI percentiles and will be compared between control and intervention group.
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline waist circumference data at 4 and 8 months
Description
Waist circumference (cm) will be evaluated and will be compared between control and intervention group.
Time Frame
"4 months" and "4 months after study cessation"
Title
Change from baseline Waist-hip ratio data at 4 and 8 months
Description
Waist-hip ratio will be evaluated by waist and hip circumference and will be compared between control and intervention group.
Time Frame
"4 months" and "4 months after study cessation"
Title
Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)
Description
Gut-derived metabolites of both groups will be evaluated by Faeces and/or plasma using NMR /GC-MS
Time Frame
4 months
Title
Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
Description
Biomarkers of oxidative stres of both groups will be evaluated by urine using ELISA
Time Frame
4 months
Title
Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)
Description
Biomarkers of inflammation of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Time Frame
4 months
Title
Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)
Description
Biomarkers of adipose tissue function of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Time Frame
4 months
Title
Change of Biomarkers of insulin resistance
Description
Biomarkers of insulin resistance of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance
Time Frame
4 months
Title
Change of biomarkers of cardiovascular risk (TMAO)
Description
Biomarkers of cardiovascular risk of both groups will be evaluated by plasma and urine using UHPLC MS
Time Frame
4 months
Title
Change of circulating levels of glucose and blood lipid profile
Description
Circulating levels of glucose and blood lipid profile of both groups will be evaluated using Enzymatic assays
Time Frame
4 months
Title
Change of Food Intake biomarkers
Description
Food Intake biomarkers of both groups will be evaluated by urine using Metabolomics (UHPLC MS)
Time Frame
4 months
Title
Change of Advanced glycation end products (AGEs) related analyses
Description
Advanced glycation end products will be assessed by plasma or erythrocytes using ELISA / enzymatic assays
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: boys and girls aged 13-17 years having obesity, defined as an age- and sex-specific BMI in the 95th percentile or greater (1), or great overweight (age- and sex-specific BMI in the ≥90th to <95th percentile), having informed consent (sign by both, one parent and the adolescent), and to have a mobile phone with internet access. Exclusion Criteria: having diabetes and other metabolic, endocrine and chronic disorders; intake of antibiotics, drug, probiotics or nutritional supplements in the last month; prescribed medicine to control hypertension, inflammation or dyslipidemia, following a prescribed diet for any reason, including weight loss, in the last 3 months; following a religion-restricted diet; and having allergies or food intolerances in: nuts, pomegranate, bread and/or chickpeas.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Caimari, PhD
Organizational Affiliation
Eurecat-Reus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurecat
City
Reus
ZIP/Postal Code
43204
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared with other researchers involved in the MED4Youth study
IPD Sharing Time Frame
Study protocol will be published in a scientific international journal. Clinical Study Report will be published at the end of the study.
IPD Sharing Access Criteria
Data will be only shared with the researchers involved in the study. Protocol and results will be shared with scientific community
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Mediterranean Enriched Diet for Tackling Youth Obesity

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