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NCT Number: NCT04719052

Mediterranean Enriched Diet for Tackling Youth Obesity

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.

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Key information

Conditions

Obesity, Adolescent Body Weight Cardiovascular Risk Factor Diet, Healthy Lifestyle, Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurecat

Reus, 43204, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet and behavioural intervention

Other

Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet

Other names: MEDITERRANEAN DIET

Primary outcomes

  1. Change from baseline BMI z-score at 4 months and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    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 outcomes

  1. Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    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

  2. Change from baseline Level of physical activity at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    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

  3. Change from baseline Habit/food intake at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    Change of Habit/food intake using 3-day dietary record, Helena study food frequency questionnaire by comparing control between intervention group

  4. Change from baseline Knowledge about food and nutrition intake at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    Change of Knowledge about food and nutrition intake using Helena's study knowledge questionnaire by comparing control between intervention group

  5. Change from baseline Life quality at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    Change of life quality using kidscreen-27 Index by comparing control between intervention group

  6. Sociodemographic data of the parents one time frame

    Time frame: 1 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.

  7. Change from baseline BMI data at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    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.

  8. Change from baseline waist circumference data at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    Waist circumference (cm) will be evaluated and will be compared between control and intervention group.

  9. Change from baseline Waist-hip ratio data at 4 and 8 months

    Time frame: "4 months" and "4 months after study cessation"

    Waist-hip ratio will be evaluated by waist and hip circumference and will be compared between control and intervention group.

  10. Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)

    Time frame: 4 months

    Gut-derived metabolites of both groups will be evaluated by Faeces and/or plasma using NMR /GC-MS

  11. Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)

    Time frame: 4 months

    Biomarkers of oxidative stres of both groups will be evaluated by urine using ELISA

  12. Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)

    Time frame: 4 months

    Biomarkers of inflammation of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance

  13. Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)

    Time frame: 4 months

    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

  14. Change of Biomarkers of insulin resistance

    Time frame: 4 months

    Biomarkers of insulin resistance of both groups will be evaluated by plasma using Magnetic bead-based multiplex assays Homeostatic Model Assessment for insulin resistance

  15. Change of biomarkers of cardiovascular risk (TMAO)

    Time frame: 4 months

    Biomarkers of cardiovascular risk of both groups will be evaluated by plasma and urine using UHPLC MS

  16. Change of circulating levels of glucose and blood lipid profile

    Time frame: 4 months

    Circulating levels of glucose and blood lipid profile of both groups will be evaluated using Enzymatic assays

  17. Change of Food Intake biomarkers

    Time frame: 4 months

    Food Intake biomarkers of both groups will be evaluated by urine using Metabolomics (UHPLC MS)

  18. Change of Advanced glycation end products (AGEs) related analyses

    Time frame: 4 months

    Advanced glycation end products will be assessed by plasma or erythrocytes using ELISA / enzymatic assays

Sponsors and collaborators

Lead sponsor

Fundació Eurecat

Other

Collaborators

  • Hospital Universitari Sant Joan de Reus
  • University of Coimbra
  • University of Parma

Registry information

Acronym: MED4Youth

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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