Clinical trial NCT04719052: Mediterranean Enriched Diet for Tackling Youth Obesity
Official title: Mediterranean Enriched Diet for Tackling Youth Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Lifestyle, Healthy
Diet, Healthy
Cardiovascular Risk Factor
Keywords: Youth Obesity
Mediterranean diet
Interventional study
Healthy lifestyles
Educational approach
Lead sponsor: Fundació Eurecat
Sponsor class: OTHER
Collaborators: name: University of Parma
name: University of Coimbra
name: Hospital Universitari Sant Joan de Reus
First posted: 2021-01-22
Enrollment: 240
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre, blind, single-randomized, parallel, clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline BMI z-score at 4 months and 8 months
timeFrame: "4 months" and "4 months after study cessation"
Secondary outcomes:
measure: Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline Level of physical activity at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline Habit/food intake at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline Knowledge about food and nutrition intake at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline Life quality at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Sociodemographic data of the parents one time frame
timeFrame: 1 time frame
measure: Change from baseline BMI data at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline waist circumference data at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change from baseline Waist-hip ratio data at 4 and 8 months
timeFrame: "4 months" and "4 months after study cessation"
measure: Change of Gut-derived metabolites (LPS, SCFAs, lactate, bile acids)
timeFrame: 4 months
measure: Change of biomarkers of oxidative stress (8-OHdG, F2-isoprostanes)
timeFrame: 4 months
measure: Change of biomarkers of inflammation (IL-6, CRP, TNFα, MCP1, IL-8)
timeFrame: 4 months
measure: Change of biomarkers of adipose tissue function (adiponectin, leptin, resistin)
timeFrame: 4 months
measure: Change of Biomarkers of insulin resistance
timeFrame: 4 months
measure: Change of biomarkers of cardiovascular risk (TMAO)
timeFrame: 4 months
measure: Change of circulating levels of glucose and blood lipid profile
timeFrame: 4 months
measure: Change of Food Intake biomarkers
timeFrame: 4 months
measure: Change of Advanced glycation end products (AGEs) related analyses
timeFrame: 4 months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Eurecat
Study officials:
affiliation: Eurecat-Reus
name: Antoni Caimari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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/
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.