Mediterranean Enriched Diet for Tackling Youth Obesity

Cardiovascular Risk Factor Clinical Trial

— MED4Youth  

Official title:

Mediterranean Enriched Diet for Tackling Youth Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04719052
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: October 2023

Study information

• Verified date: July 2023
• Source: Fundació Eurecat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diet, Healthy
• Lifestyle, Healthy
• Obesity
• Obesity, Adolescent
• Pediatric Obesity

Intervention

Other:
• Diet and behavioural intervention
Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet
• Diet and behavioural intervention
Control group will receive a specific diet designed following the characteristics of Low fat Diet.

Locations

Country	Name	City	State
Spain	Eurecat	Reus

Sponsors (4)

Lead Sponsor	Collaborator
Fundació Eurecat	Hospital Universitari Sant Joan de Reus, University of Coimbra, University of Parma

Country where clinical trial is conducted

Spain, 

References & Publications (21)

Abbondio M, Palomba A, Tanca A, Fraumene C, Pagnozzi D, Serra M, Marongiu F, Laconi E, Uzzau S. Fecal Metaproteomic Analysis Reveals Unique Changes of the Gut Microbiome Functions After Consumption of Sourdough Carasau Bread. Front Microbiol. 2019 Jul 30;10:1733. doi: 10.3389/fmicb.2019.01733. eCollection 2019. — View Citation

Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Cabre-Vila JJ, Salas-Salvado J. Effects of one serving of mixed nuts on serum lipids, insulin resistance and inflammatory markers in patients with the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2011 Feb;21(2):126-35. doi: 10.1016/j.numecd.2009.08.005. Epub 2009 Dec 22. — View Citation

Castro-Quezada I, Roman-Vinas B, Serra-Majem L. The Mediterranean diet and nutritional adequacy: a review. Nutrients. 2014 Jan 3;6(1):231-48. doi: 10.3390/nu6010231. — View Citation

Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678. — View Citation

Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and weight loss: meta-analysis of randomized controlled trials. Metab Syndr Relat Disord. 2011 Feb;9(1):1-12. doi: 10.1089/met.2010.0031. Epub 2010 Oct 25. — View Citation

Gheflati A, Mohammadi M, Ramezani-Jolfaie N, Heidari Z, Salehi-Abargouei A, Nadjarzadeh A. Does pomegranate consumption affect weight and body composition? A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2019 May;33(5):1277-1288. doi: 10.1002/ptr.6322. Epub 2019 Mar 18. — View Citation

Guideline: Assessing and Managing Children at Primary Health-Care Facilities to Prevent Overweight and Obesity in the Context of the Double Burden of Malnutrition: Updates for the Integrated Management of Childhood Illness (IMCI). Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK487902/ — View Citation

Ho M, Garnett SP, Baur LA, Burrows T, Stewart L, Neve M, Collins C. Impact of dietary and exercise interventions on weight change and metabolic outcomes in obese children and adolescents: a systematic review and meta-analysis of randomized trials. JAMA Pediatr. 2013 Aug 1;167(8):759-68. doi: 10.1001/jamapediatrics.2013.1453. — View Citation

Hofsteenge GH, Chinapaw MJ, Delemarre-van de Waal HA, Weijs PJ. Validation of predictive equations for resting energy expenditure in obese adolescents. Am J Clin Nutr. 2010 May;91(5):1244-54. doi: 10.3945/ajcn.2009.28330. Epub 2010 Mar 17. — View Citation

Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12. — View Citation

Kelishadi R, Gidding SS, Hashemi M, Hashemipour M, Zakerameli A, Poursafa P. Acute and long term effects of grape and pomegranate juice consumption on endothelial dysfunction in pediatric metabolic syndrome. J Res Med Sci. 2011 Mar;16(3):245-53. — View Citation

Kerimi A, Nyambe-Silavwe H, Gauer JS, Tomas-Barberan FA, Williamson G. Pomegranate juice, but not an extract, confers a lower glycemic response on a high-glycemic index food: randomized, crossover, controlled trials in healthy subjects. Am J Clin Nutr. 2017 Dec;106(6):1384-1393. doi: 10.3945/ajcn.117.161968. Epub 2017 Oct 11. — View Citation

Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1. — View Citation

Miller AL, Lee HJ, Lumeng JC. Obesity-associated biomarkers and executive function in children. Pediatr Res. 2015 Jan;77(1-2):143-7. doi: 10.1038/pr.2014.158. Epub 2014 Oct 13. — View Citation

Salas-Salvado J, Diaz-Lopez A, Ruiz-Canela M, Basora J, Fito M, Corella D, Serra-Majem L, Warnberg J, Romaguera D, Estruch R, Vidal J, Martinez JA, Aros F, Vazquez C, Ros E, Vioque J, Lopez-Miranda J, Bueno-Cavanillas A, Tur JA, Tinahones FJ, Martin V, Lapetra J, Pinto X, Daimiel L, Delgado-Rodriguez M, Matia P, Gomez-Gracia E, Diez-Espino J, Babio N, Castaner O, Sorli JV, Fiol M, Zulet MA, Bullo M, Goday A, Martinez-Gonzalez MA; PREDIMED-Plus investigators. Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial. Diabetes Care. 2019 May;42(5):777-788. doi: 10.2337/dc18-0836. Epub 2018 Nov 2. — View Citation

Schroder H, Mendez MA, Ribas-Barba L, Covas MI, Serra-Majem L. Mediterranean diet and waist circumference in a representative national sample of young Spaniards. Int J Pediatr Obes. 2010 Dec;5(6):516-9. doi: 10.3109/17477161003777417. Epub 2010 Sep 23. — View Citation

Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556. — View Citation

Stamataki NS, Yanni AE, Karathanos VT. Bread making technology influences postprandial glucose response: a review of the clinical evidence. Br J Nutr. 2017 Apr;117(7):1001-1012. doi: 10.1017/S0007114517000770. Epub 2017 May 2. — View Citation

US Preventive Services Task Force; Grossman DC, Bibbins-Domingo K, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Obesity in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Jun 20;317(23):2417-2426. doi: 10.1001/jama.2017.6803. — View Citation

Velazquez-Lopez L, Santiago-Diaz G, Nava-Hernandez J, Munoz-Torres AV, Medina-Bravo P, Torres-Tamayo M. Mediterranean-style diet reduces metabolic syndrome components in obese children and adolescents with obesity. BMC Pediatr. 2014 Jul 5;14:175. doi: 10.1186/1471-2431-14-175. — View Citation

Wallace TC, Murray R, Zelman KM. The Nutritional Value and Health Benefits of Chickpeas and Hummus. Nutrients. 2016 Nov 29;8(12):766. doi: 10.3390/nu8120766. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	"4 months" and "4 months after study cessation"
Secondary	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	"4 months" and "4 months after study cessation"
Secondary	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	"4 months" and "4 months after study cessation"
Secondary	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	"4 months" and "4 months after study cessation"
Secondary	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	"4 months" and "4 months after study cessation"
Secondary	Change from baseline Life quality at 4 and 8 months	Change of life quality using kidscreen-27 Index by comparing control between intervention group	"4 months" and "4 months after study cessation"
Secondary	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.	1 time frame
Secondary	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.	"4 months" and "4 months after study cessation"
Secondary	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.	"4 months" and "4 months after study cessation"
Secondary	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.	"4 months" and "4 months after study cessation"
Secondary	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	4 months
Secondary	Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)	Biomarkers of oxidative stres of both groups will be evaluated by urine using ELISA	4 months
Secondary	Change of biomarkers of inflammation (IL-6, CRP, TNFa, 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	4 months
Secondary	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	4 months
Secondary	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	4 months
Secondary	Change of biomarkers of cardiovascular risk (TMAO)	Biomarkers of cardiovascular risk of both groups will be evaluated by plasma and urine using UHPLC MS	4 months
Secondary	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	4 months
Secondary	Change of Food Intake biomarkers	Food Intake biomarkers of both groups will be evaluated by urine using Metabolomics (UHPLC MS)	4 months
Secondary	Change of Advanced glycation end products (AGEs) related analyses	Advanced glycation end products will be assessed by plasma or erythrocytes using ELISA / enzymatic assays	4 months