ObesityNCT01890070
Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet
A study testing Hazelnuts, Chocolate and Red wine in people with Obesity, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods conforming to the Mediterranean diet, in order to determine the effect functional foods have on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function, inflammation, nutritional status) and body… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Hazelnuts, Chocolate and Red wine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jan 2016
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 75 years inclusive BMI >19 kg/m2
- -
Who cannot join
- Past history of ischaemic coronary artery disease
- Peripheral or cerebral vasculopathy
- Hepatic disease
- Diabetes Mellitus
- Autoimmune disease
- HIV/AIDS
- Neoplastic disease
- Use of the following medications: lipid-lowering medications, oral anti-diabetic medication or insulin, nitroglycerin, corticosteroids.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata
Rome, Rome, 00133
Laura Di Renzo, Phd
About this study
Official title: Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study
The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods conforming to the Mediterranean diet, in order to determine the effect functional foods have on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function, inflammation, nutritional status) and body composition in the context of four different diets (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of these nutraceutical foods in relation to different diets. Diets were chosen to reflect the standard reference diets used by the general population, so as the outcomes of the addition of each interventional food element may be interpreted in the context of a variety of dietary patterns.
Read the detailed description
This study envisages the enrollment of subjects, to be recruited consecutively from May 2013 to May 2015 from the staff of the laboratory of the Evaluation of Nutritional State, Nutrigenetics and nutrigenomics of the Human Nutrition and Diet section of the University of Rome Tor Vergata.
The study will be conducted in accordance with the Declaration of Helsinki, and approved by the Committee of the Ministero delle Politiche Alimentari e Forestali (MIPAAF) , Italy, approved by DM 06/12/2011 n° prot. 32064. All participants will be required to provide written informed consent for the study.
At the time of recruitment, relevant subject data will be collected including clinical history, dietary habits, pharmacological therapy, smoking habit, alcohol consumption and level of physical activity.
Exclusion criteria include history of coronary vascular disease, peripheral or cerebro- vascular disease, hepatic disease, diagnosis of diabetes mellitus, autoimmune disease, immunodeficiency syndrome or malignant neoplasia.
The subjects enrolled will undergo:
- Anthropometric measures (body weight, height, waist, hip, abdominal, neck, arm and forearm circumferences).
- Skin fold measurements (bicipital, tricipital, subscapular, pectoral, supra iliac, abdominal, anterior thigh, internal thigh, supra patellar and popliteal);
- Blood Pressure;
- Body composition evaluation (bone, fat and lean mass), evaluated by DEXA (iDXA; GE
- Medical Systems, Milwaukee, WI) (Dual energy X-ray Absorptiometry; DPX Lunar Radiation Corp., Madison, Wisconsin, USA);
- Distribution of body fluids, evaluated by bioimpedensometry. Resistance, reactance, phase angle at 50 kHz will be measured using the Bioelectrical Impedance Analysis method (BIA 101S, by Akern/RIL System-Florence
- Analysis of genetic expression Participants will be randomized into groups.
Each group will cycle through different interventions, according to a cross over study. The interventions are represented by different dietary plans based on different meals, consisting of:
- Standard Diet (SD) alone, and SD with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate);
- High Fat diet (HF) alone, and HF with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
- Low Carbohydrate diet (LC) alone, and LC with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
- High Protein (HP) alone, and HP with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
The duration of the experimental period is 4 weeks for each diet, with a wash-out period of 3 weeks at the beginning of the study between one diet and the next.
- Conditions
- Obesity
- Being tested
- Hazelnuts, Chocolate, Red wine, Olive Oil, Wild mixed greens
- Keywords
- mediterranean diet, nutrigenomics, body composition, inflammation, oxidative stress
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HazelnutsDietary supplement
Also called Corylus avellana
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
ChocolateDietary supplement
Also called Theobroma cacao
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Red wineDietary supplement
Also called Vitis vinifera
Italian Organic Red Wine
Olive OilDietary supplement
Also called Olea europea
Italian Organic Olive Oil
Wild mixed greensDietary supplement
Also called Chicory, rocket, nettle
Italian organic wild mixed greens
ChestnutDietary supplement
Also called Castanea sativa
Italian Organic Chestnut
No Dietary SupplementOther
Mediterranean Reference Diet, High Fat Diet, Low Carbohydrate or High Protein Diet without an added dietary supplement (hazelnut, chocolate, red wine, wild mixed greens, chestnuts, olive oil)
| Study group | Role | What they receive |
|---|---|---|
| STANDARD DIET | Placebo comparator | each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fiber)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Other: No Dietary Supplement |
| STANDARD DIET WITH HAZELNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Hazelnuts |
| STANDARD DIET WITH RED WINE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day :
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 ml of Italian organic Red Wine.
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Red wine |
| STANDARD DIET WITH CHESTNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Italian organic chestnuts.
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chestnut |
| STANDARD DIET WITH CHOCOLATE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day :
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chocolate |
| STANDARD DIET WITH WILD MIXED GREEN | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 g of Italian organic wild mixed green
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Wild mixed greens |
| STANDARD DIET WITH OLIVE OIL | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient patient is required to consume per day :
Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100g of Italian organic Olive Oil
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Olive Oil |
| HIGH FAT DIET | Placebo comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Other: No Dietary Supplement |
| HIGH FAT WITH HAZELNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 40g of Italian hazelnuts from Piedmont with Protected Geographical Indication Certification.
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Hazelnuts |
| HIGH FAT WITH RED WINE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%)with 200 ml of Italian organic Red Wine
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Red wine |
| HIGH FAT WITH CHESTNUT | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Italian organic chestnuts.
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chestnut |
| HIGH FAT WITH CHOCOLATE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chocolate |
| HIGH FAT WITH WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 200 g of Italian organic wild mixed green
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Wild mixed greens |
| HIGH FAT WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 of Italian organic Olive oil
Three weeks of washout to avoid additive effects on treatment following. Receives: Dietary Supplement: Olive Oil |
| LOW CARBOHYDRATE DIET | Placebo comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Other: No Dietary Supplement |
| LOW CARBOHYDRATE DIET WITH HAZELNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Hazelnuts |
| LOW CARBOHYDRATE DIET WITH RED WINE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 ml of Italian organic Red Wine
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Red wine |
| LOW CARBOHYDRATE DIET WITH CHESTNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Italian organic chestnuts
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chestnut |
| LOW CARBOHYDRATE DIET CHOCOLATE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chocolate |
| LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 g of Italian organic wild mixed green
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Wild mixed greens |
| LOW CARBOHYDRATE DIET WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 of Italian organic Olive Oil
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Olive Oil |
| HIGH PROTEIN DIET | Placebo comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Other: No Dietary Supplement |
| HIGH PROTEIN DIET WITH HAZELNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification Receives: Dietary Supplement: Hazelnuts |
| HIGH PROTEIN DIET WITH RED WINE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 ml of Italian organic Red Wine
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Red wine |
| HIGH PROTEIN DIET WITH CHESTNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Italian organic chestnuts
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chestnut |
| HIGH PROTEIN DIET WITH CHOCOLATE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Chocolate |
| HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 g of Italian organic wild mixed green
Three weeks of washout to avoid additive effects on treatments to follow. Receives: Dietary Supplement: Wild mixed greens |
| HIGH PROTEIN DIET WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day:
High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 of Italian organic Olive Oil
This is followed by a 3 week wash out period, to neutralize any additive effects. Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenic index
To calculate the sarcopenic index three calculations will be made: Body Cell Mass Index from bioelectrical impedance analysis (body cell mass in kilograms divided by height in metres squared),and the Appendicular Skeletal Muscle Index (sum of appendicular muscle mass divided by height in metres squared)and Relative Skeletal Muscle Index (total body lean mass divided by height in metres squared)both calculated from dual-energy X-ray asorptiometry.
Measured: Variation in sarcopenic index from baseline to 4 weeks
Secondary outcomes (4)
Cardiovascular Risk Index
Cardiovascular Risk Index will be calculated from 3 formulas: Total Cholesterol (mg/dl) divided by High Density Lipoprotein (mg/dl), Low Density Lipoprotein (mg/dl) divided by High Density Lipoprotein (mg/dl), Log10 Triglycerides (mg/dl) divided by High Density Lipoprotein (mg/dl)
Measured: Variation in cardiovascular risk index from baseline to 4 weeks
Homeostatic Model Assessment (HOMA-IR)
HOMA will be calculated as follows: Blood glucose (mmol/L) x Blood Insulin (mU/L) divided by 22.5
Measured: Variation in HOMA from baseline to 4 weeks
Prognostic Inflammatory and Nutritional Index (PINI)
PINI will be calculated as follows: [C-reactive Protein (mg/L) multiplied by alpha-1 acid glycoprotein (g/L)] divided by [albumin (g/L) multiplied by prealbumin (g/L)]
Measured: Variation in PINI from baseline to 4 weeks
Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB)
Measurement of gene up-regulation or down-regulation in order of magnitude set at ±2FC (fundamental-costant-based system of units)
Measured: Variation in expression of NFkappaB from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAURA DI RENZO, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890070
- Sponsor's protocol ID
- DM 06/12/2011 n° prot. 32064
- Status last verified
- Dec 2015
- First submitted
- 24 Jun 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Di Renzo L, Frank G, Pala B, Cianci R, De Santis GL, Nicoletti F, Bigioni G, Ortoman M, Borro M, Simmaco M, Peluso D, De Lorenzo A, Gualtieri P. Characterization of Gut Microbiota Profile in Lipedema: A Pilot Study. Nutrients. 2025 Dec 13;17(24):3909. doi: 10.3390/nu17243909.
PubMed 41470854Di Renzo L, Gualtieri P, Frank G, Cianci R, Raffaelli G, Peluso D, Bigioni G, De Lorenzo A. Sex-Specific Adherence to the Mediterranean Diet in Obese Individuals. Nutrients. 2024 Sep 12;16(18):3076. doi: 10.3390/nu16183076.
PubMed 39339676Gualtieri P, Marchetti M, Frank G, Smeriglio A, Trombetta D, Colica C, Cianci R, De Lorenzo A, Di Renzo L. Antioxidant-Enriched Diet on Oxidative Stress and Inflammation Gene Expression: A Randomized Controlled Trial. Genes (Basel). 2023 Jan 13;14(1):206. doi: 10.3390/genes14010206.
PubMed 36672947Marchetti M, Gualtieri P, De Lorenzo A, Trombetta D, Smeriglio A, Ingegneri M, Cianci R, Frank G, Schifano G, Bigioni G, Di Renzo L. Dietary omega-3 intake for the treatment of morning headache: A randomized controlled trial. Front Neurol. 2022 Sep 20;13:987958. doi: 10.3389/fneur.2022.987958. eCollection 2022.
PubMed 36203988Perrone MA, Gualtieri P, Gratteri S, Ali W, Sergi D, Muscoli S, Cammarano A, Bernardini S, Di Renzo L, Romeo F. Effects of postprandial hydroxytyrosol and derivates on oxidation of LDL, cardiometabolic state and gene expression: a nutrigenomic approach for cardiovascular prevention. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):419-426. doi: 10.2459/JCM.0000000000000816.
PubMed 31593559Di Renzo L, Cioccoloni G, Falco S, Abenavoli L, Moia A, Sinibaldi Salimei P, De Lorenzo A. Influence of FTO rs9939609 and Mediterranean diet on body composition and weight loss: a randomized clinical trial. J Transl Med. 2018 Nov 12;16(1):308. doi: 10.1186/s12967-018-1680-7.
PubMed 30419927Colica C, Avolio E, Bollero P, Costa de Miranda R, Ferraro S, Sinibaldi Salimei P, De Lorenzo A, Di Renzo L. Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety. Mediators Inflamm. 2017;2017:5650627. doi: 10.1155/2017/5650627. Epub 2017 Sep 24.
PubMed 29147070Colica C, Di Renzo L, Trombetta D, Smeriglio A, Bernardini S, Cioccoloni G, Costa de Miranda R, Gualtieri P, Sinibaldi Salimei P, De Lorenzo A. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial. Oxid Med Cell Longev. 2017;2017:2473495. doi: 10.1155/2017/2473495. Epub 2017 Aug 9.
PubMed 28855976De Lorenzo A, Costacurta M, Merra G, Gualtieri P, Cioccoloni G, Marchetti M, Varvaras D, Docimo R, Di Renzo L. Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial. J Transl Med. 2017 Jun 10;15(1):135. doi: 10.1186/s12967-017-1236-2.
PubMed 28601084Colica C, Merra G, Gasbarrini A, De Lorenzo A, Cioccoloni G, Gualtieri P, Perrone MA, Bernardini S, Bernardo V, Di Renzo L, Marchetti M. Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2274-2289.
PubMed 28537652Di Renzo L, Merra G, Botta R, Gualtieri P, Manzo A, Perrone MA, Mazza M, Cascapera S, De Lorenzo A. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial. Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1610-1626.
PubMed 28429343De Lorenzo A, Bernardini S, Gualtieri P, Cabibbo A, Perrone MA, Giambini I, Di Renzo L. Mediterranean meal versus Western meal effects on postprandial ox-LDL, oxidative and inflammatory gene expression in healthy subjects: a randomized controlled trial for nutrigenomic approach in cardiometabolic risk. Acta Diabetol. 2017 Feb;54(2):141-149. doi: 10.1007/s00592-016-0917-2. Epub 2016 Oct 5.
PubMed 27709360Di Renzo L, Tyndall E, Gualtieri P, Carboni C, Valente R, Ciani AS, Tonini MG, De Lorenzo A. Association of body composition and eating behavior in the normal weight obese syndrome. Eat Weight Disord. 2016 Mar;21(1):99-106. doi: 10.1007/s40519-015-0215-y. Epub 2015 Sep 7.
PubMed 26347355Di Renzo L, Marsella LT, Sarlo F, Soldati L, Gratteri S, Abenavoli L, De Lorenzo A. C677T gene polymorphism of MTHFR and metabolic syndrome: response to dietary intervention. J Transl Med. 2014 Nov 29;12:329. doi: 10.1186/s12967-014-0329-4.
PubMed 25432492Di Renzo L, Carraro A, Valente R, Iacopino L, Colica C, De Lorenzo A. Intake of red wine in different meals modulates oxidized LDL level, oxidative and inflammatory gene expression in healthy people: a randomized crossover trial. Oxid Med Cell Longev. 2014;2014:681318. doi: 10.1155/2014/681318. Epub 2014 Apr 30.
PubMed 24876915
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study
- ClinicalTrials.gov ID
- NCT01890070
- Acronym / sponsor ID
- DM 06/12/2011 n° prot. 32064
- Conditions
- Obesity
- Keywords
- mediterranean diet, nutrigenomics, body composition, inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 1 Jul 2013 (estimated)
- 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.
The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods conforming to the Mediterranean diet, in order to determine the effect functional foods have on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function, inflammation, nutritional status) and body composition in the context of four different diets (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of these nutraceutical foods in relation to different diets. Diets were chosen to reflect the standard reference diets used by the general population, so as the outcomes of the addition of each interventional food element may be interpreted in the context of a variety of dietary patterns.
Detailed description
This study envisages the enrollment of subjects, to be recruited consecutively from May 2013 to May 2015 from the staff of the laboratory of the Evaluation of Nutritional State, Nutrigenetics and nutrigenomics of the Human Nutrition and Diet section of the University of Rome Tor Vergata.
The study will be conducted in accordance with the Declaration of Helsinki, and approved by the Committee of the Ministero delle Politiche Alimentari e Forestali (MIPAAF) , Italy, approved by DM 06/12/2011 n° prot. 32064. All participants will be required to provide written informed consent for the study.
At the time of recruitment, relevant subject data will be collected including clinical history, dietary habits, pharmacological therapy, smoking habit, alcohol consumption and level of physical activity.
Exclusion criteria include history of coronary vascular disease, peripheral or cerebro- vascular disease, hepatic disease, diagnosis of diabetes mellitus, autoimmune disease, immunodeficiency syndrome or malignant neoplasia.
The subjects enrolled will undergo:
- Anthropometric measures (body weight, height, waist, hip, abdominal, neck, arm and forearm circumferences).
- Skin fold measurements (bicipital, tricipital, subscapular, pectoral, supra iliac, abdominal, anterior thigh, internal thigh, supra patellar and popliteal);
- Blood Pressure;
- Body composition evaluation (bone, fat and lean mass), evaluated by DEXA (iDXA; GE
- Medical Systems, Milwaukee, WI) (Dual energy X-ray Absorptiometry; DPX Lunar Radiation Corp., Madison, Wisconsin, USA);
- Distribution of body fluids, evaluated by bioimpedensometry. Resistance, reactance, phase angle at 50 kHz will be measured using the Bioelectrical Impedance Analysis method (BIA 101S, by Akern/RIL System-Florence
- Analysis of genetic expression Participants will be randomized into groups.
Each group will cycle through different interventions, according to a cross over study. The interventions are represented by different dietary plans based on different meals, consisting of:
- Standard Diet (SD) alone, and SD with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate);
- High Fat diet (HF) alone, and HF with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
- Low Carbohydrate diet (LC) alone, and LC with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
- High Protein (HP) alone, and HP with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
The duration of the experimental period is 4 weeks for each diet, with a wash-out period of 3 weeks at the beginning of the study between one diet and the next.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| STANDARD DIET | Placebo comparator | Other: No Dietary Supplementeach patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fiber) Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH HAZELNUTS | Experimental | Dietary Supplement: HazelnutsIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH RED WINE | Experimental | Dietary Supplement: Red wineIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 ml of Italian organic Red Wine. Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH CHESTNUTS | Experimental | Dietary Supplement: ChestnutIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Italian organic chestnuts. Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH CHOCOLATE | Experimental | Dietary Supplement: ChocolateIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH WILD MIXED GREEN | Experimental | Dietary Supplement: Wild mixed greensIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
| STANDARD DIET WITH OLIVE OIL | Experimental | Dietary Supplement: Olive OilIntervention type: each patient is administered a food plan for four weeks. Every patient patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100g of Italian organic Olive Oil Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT DIET | Placebo comparator | Other: No Dietary SupplementIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH HAZELNUTS | Experimental | Dietary Supplement: HazelnutsIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 40g of Italian hazelnuts from Piedmont with Protected Geographical Indication Certification. Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH RED WINE | Experimental | Dietary Supplement: Red wineIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%)with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH CHESTNUT | Experimental | Dietary Supplement: ChestnutIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Italian organic chestnuts. Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH CHOCOLATE | Experimental | Dietary Supplement: ChocolateIntervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH WILD MIXED GREEN | Experimental | Dietary Supplement: Wild mixed greensIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH FAT WITH OLIVE OIL | Experimental | Dietary Supplement: Olive OilIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 of Italian organic Olive oil Three weeks of washout to avoid additive effects on treatment following. |
| LOW CARBOHYDRATE DIET | Placebo comparator | Other: No Dietary SupplementIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET WITH HAZELNUT | Experimental | Dietary Supplement: HazelnutsIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET WITH RED WINE | Experimental | Dietary Supplement: Red wineIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET WITH CHESTNUT | Experimental | Dietary Supplement: ChestnutIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Italian organic chestnuts Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET CHOCOLATE | Experimental | Dietary Supplement: ChocolateIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN | Experimental | Dietary Supplement: Wild mixed greensIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
| LOW CARBOHYDRATE DIET WITH OLIVE OIL | Experimental | Dietary Supplement: Olive OilIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 of Italian organic Olive Oil Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET | Placebo comparator | Other: No Dietary SupplementIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET WITH HAZELNUT | Experimental | Dietary Supplement: HazelnutsIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification |
| HIGH PROTEIN DIET WITH RED WINE | Experimental | Dietary Supplement: Red wineIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET WITH CHESTNUT | Experimental | Dietary Supplement: ChestnutIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Italian organic chestnuts Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET WITH CHOCOLATE | Experimental | Dietary Supplement: ChocolateIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN | Experimental | Dietary Supplement: Wild mixed greensIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
| HIGH PROTEIN DIET WITH OLIVE OIL | Experimental | Dietary Supplement: Olive OilIntervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 of Italian organic Olive Oil This is followed by a 3 week wash out period, to neutralize any additive effects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 75 years inclusive BMI >19 kg/m2
- -
Key exclusion criteria (8 listed)
- Past history of ischaemic coronary artery disease
- Peripheral or cerebral vasculopathy
- Hepatic disease
- Diabetes Mellitus
- Autoimmune disease
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 |
|---|---|---|
| HazelnutsAlso: Corylus avellanaItalian hazelnuts from Piedmont with Protected Geographical Indication Certification | Dietary supplement | HIGH FAT WITH HAZELNUTS, HIGH PROTEIN DIET WITH HAZELNUT, LOW CARBOHYDRATE DIET WITH HAZELNUT, STANDARD DIET WITH HAZELNUTS |
| ChocolateAlso: Theobroma cacaoExtra-dark Italian Chocolate (min. 70% of organic cocoa solids) | Dietary supplement | HIGH FAT WITH CHOCOLATE, HIGH PROTEIN DIET WITH CHOCOLATE, LOW CARBOHYDRATE DIET CHOCOLATE, STANDARD DIET WITH CHOCOLATE |
| Red wineAlso: Vitis viniferaItalian Organic Red Wine | Dietary supplement | HIGH FAT WITH RED WINE, HIGH PROTEIN DIET WITH RED WINE, LOW CARBOHYDRATE DIET WITH RED WINE, STANDARD DIET WITH RED WINE |
| Olive OilAlso: Olea europeaItalian Organic Olive Oil | Dietary supplement | HIGH FAT WITH OLIVE OIL, HIGH PROTEIN DIET WITH OLIVE OIL, LOW CARBOHYDRATE DIET WITH OLIVE OIL, STANDARD DIET WITH OLIVE OIL |
| Wild mixed greensAlso: Chicory, rocket, nettleItalian organic wild mixed greens | Dietary supplement | HIGH FAT WITH WILD MIXED GREEN, HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN, LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN, STANDARD DIET WITH WILD MIXED GREEN |
| ChestnutAlso: Castanea sativaItalian Organic Chestnut | Dietary supplement | HIGH FAT WITH CHESTNUT, HIGH PROTEIN DIET WITH CHESTNUT, LOW CARBOHYDRATE DIET WITH CHESTNUT, STANDARD DIET WITH CHESTNUTS |
| No Dietary SupplementMediterranean Reference Diet, High Fat Diet, Low Carbohydrate or High Protein Diet without an added dietary supplement (hazelnut, chocolate, red wine, wild mixed greens, chestnuts, olive oil) | Other | HIGH FAT DIET, HIGH PROTEIN DIET, LOW CARBOHYDRATE DIET, STANDARD DIET |
Primary outcome
Sarcopenic index
Time frame: Variation in sarcopenic index from baseline to 4 weeks
To calculate the sarcopenic index three calculations will be made: Body Cell Mass Index from bioelectrical impedance analysis (body cell mass in kilograms divided by height in metres squared),and the Appendicular Skeletal Muscle Index (sum of appendicular muscle mass divided by height in metres squared)and Relative Skeletal Muscle Index (total body lean mass divided by height in metres squared)both calculated from dual-energy X-ray asorptiometry.
4 secondary outcomes
Cardiovascular Risk Index
Time frame: Variation in cardiovascular risk index from baseline to 4 weeks
Homeostatic Model Assessment (HOMA-IR)
Time frame: Variation in HOMA from baseline to 4 weeks
Prognostic Inflammatory and Nutritional Index (PINI)
Time frame: Variation in PINI from baseline to 4 weeks
Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB)
Time frame: Variation in expression of NFkappaB from baseline to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Derived from this study: PubMed 41470854Di Renzo L, Frank G, Pala B, Cianci R, De Santis GL, Nicoletti F, Bigioni G, Ortoman M, Borro M, Simmaco M, Peluso D, De Lorenzo A, Gualtieri P. Characterization of Gut Microbiota Profile in Lipedema: A Pilot Study. Nutrients. 2025 Dec 13;17(24):3909. doi: 10.3390/nu17243909.
- Derived from this study: PubMed 39339676Di Renzo L, Gualtieri P, Frank G, Cianci R, Raffaelli G, Peluso D, Bigioni G, De Lorenzo A. Sex-Specific Adherence to the Mediterranean Diet in Obese Individuals. Nutrients. 2024 Sep 12;16(18):3076. doi: 10.3390/nu16183076.
- Derived from this study: PubMed 36672947Gualtieri P, Marchetti M, Frank G, Smeriglio A, Trombetta D, Colica C, Cianci R, De Lorenzo A, Di Renzo L. Antioxidant-Enriched Diet on Oxidative Stress and Inflammation Gene Expression: A Randomized Controlled Trial. Genes (Basel). 2023 Jan 13;14(1):206. doi: 10.3390/genes14010206.
- Derived from this study: PubMed 36203988Marchetti M, Gualtieri P, De Lorenzo A, Trombetta D, Smeriglio A, Ingegneri M, Cianci R, Frank G, Schifano G, Bigioni G, Di Renzo L. Dietary omega-3 intake for the treatment of morning headache: A randomized controlled trial. Front Neurol. 2022 Sep 20;13:987958. doi: 10.3389/fneur.2022.987958. eCollection 2022.
- Derived from this study: PubMed 31593559Perrone MA, Gualtieri P, Gratteri S, Ali W, Sergi D, Muscoli S, Cammarano A, Bernardini S, Di Renzo L, Romeo F. Effects of postprandial hydroxytyrosol and derivates on oxidation of LDL, cardiometabolic state and gene expression: a nutrigenomic approach for cardiovascular prevention. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):419-426. doi: 10.2459/JCM.0000000000000816.
- Derived from this study: PubMed 30419927Di Renzo L, Cioccoloni G, Falco S, Abenavoli L, Moia A, Sinibaldi Salimei P, De Lorenzo A. Influence of FTO rs9939609 and Mediterranean diet on body composition and weight loss: a randomized clinical trial. J Transl Med. 2018 Nov 12;16(1):308. doi: 10.1186/s12967-018-1680-7.
- Derived from this study: PubMed 29147070Colica C, Avolio E, Bollero P, Costa de Miranda R, Ferraro S, Sinibaldi Salimei P, De Lorenzo A, Di Renzo L. Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety. Mediators Inflamm. 2017;2017:5650627. doi: 10.1155/2017/5650627. Epub 2017 Sep 24.
- Derived from this study: PubMed 28855976Colica C, Di Renzo L, Trombetta D, Smeriglio A, Bernardini S, Cioccoloni G, Costa de Miranda R, Gualtieri P, Sinibaldi Salimei P, De Lorenzo A. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial. Oxid Med Cell Longev. 2017;2017:2473495. doi: 10.1155/2017/2473495. Epub 2017 Aug 9.
- Derived from this study: PubMed 28601084De Lorenzo A, Costacurta M, Merra G, Gualtieri P, Cioccoloni G, Marchetti M, Varvaras D, Docimo R, Di Renzo L. Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial. J Transl Med. 2017 Jun 10;15(1):135. doi: 10.1186/s12967-017-1236-2.
- Derived from this study: PubMed 28537652Colica C, Merra G, Gasbarrini A, De Lorenzo A, Cioccoloni G, Gualtieri P, Perrone MA, Bernardini S, Bernardo V, Di Renzo L, Marchetti M. Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2274-2289.
- Derived from this study: PubMed 28429343Di Renzo L, Merra G, Botta R, Gualtieri P, Manzo A, Perrone MA, Mazza M, Cascapera S, De Lorenzo A. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial. Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1610-1626.
- Derived from this study: PubMed 27709360De Lorenzo A, Bernardini S, Gualtieri P, Cabibbo A, Perrone MA, Giambini I, Di Renzo L. Mediterranean meal versus Western meal effects on postprandial ox-LDL, oxidative and inflammatory gene expression in healthy subjects: a randomized controlled trial for nutrigenomic approach in cardiometabolic risk. Acta Diabetol. 2017 Feb;54(2):141-149. doi: 10.1007/s00592-016-0917-2. Epub 2016 Oct 5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hazelnuts, Chocolate and Red wine in people with Obesity, run by University of Rome Tor Vergata at 1 site in Italy.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Di Renzo, PhD (+39 0672596855, laura.di.renzo@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenic index (time frame: Variation in sarcopenic index from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890070, which also lists 15 linked publications.
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 10 Dec 2015.