Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03870984
Other study ID # VRINoci
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date May 18, 2022

Study information

Verified date May 2022
Source Universita di Verona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is a problem of ever-growing importance, especially in industrialized countries, both in adults and in the pediatric population. Children and obese adolescents, like adults, have an increased risk, compared with normal-weight peers, to develop metabolic syndrome and atherosclerotic disease, pathophysiological basis of cardiovascular events. Alteration of the elastic properties of the arteries has been described previously in obese children and adolescents and is considered an initial marker of atherosclerotic vascular damage. The determination of the indices of arterial stiffness (PWV, Pulse Wave Velocity; AI, Augmentation Index, SI, Stiffness Index) is possible through techniques currently used for the determination of vascular function even in children. Nuts and hazelnuts are rich in potentially beneficial substances including unsaturated fatty acids, especially omega-6 (present in both) and omega-3 (present only in nuts), Several clinical trials have already shown in adults a potential beneficial effect of the addition of different types of nuts (walnuts, hazelnuts, cashews, pistachios, etc.) on the characteristics of the metabolic syndrome also through their possible antioxidant effect and vasoactive. In children, some epidemiological studies have associated with a higher consumption of nuts reduced risk of hypertension, dyslipidemia, obesity and fasting glucose. The study will be conducted with a randomized design with two arms in parallel with blinded operator. The main objective of this study is to assess the efficacy of 15 grams of nuts and 15 grams of nuts a day in addition to a low calorie diet on the content of erythrocyte membranes of alpha-linolenic acid three months after the beginning of the trial in a group of obese children. Secondary objectives are to evaluate the efficacy of walnuts and hazelnuts in improving the systolic and/or diastolic blood pressure values, lipid profile, glucose and fasting insulin, vascular function.


Description:

Obesity is a problem of ever-growing importance, especially in industrialized countries, widespread both in adults and in the pediatric population. Children and obese adolescents, like adults, have an increased risk, compared with normal-weight peers, to develop high blood pressure, insulin resistance, diabetes, hyperlipidemia, fatty liver disease and the resulting long-term complications. This cluster of metabolic and hemodynamic risk factors, which is known as metabolic syndrome, greatly increases the risk of cardiovascular events in adults. Cardiovascular disease is the leading cause of mortality and morbidity in developed countries and are becoming even in developing countries. Atherosclerotic disease is the pathophysiological basis of cardiovascular events. Atherosclerosis is a multifactorial disease whose early stages of subclinical damage are documented much earlier in cardiovascular events with non-invasive tests. The determination of the indices of arterial stiffness (PWV, Pulse Wave Velocity; AI, Augmentation Index, SI, Stiffness Index) is possible through techniques currently used for the determination of vascular function even in children. The alteration of the elastic properties of the arteries has been described previously in obese children and adolescents and is considered initial marker atherosclerotic vascular damage. Fats particularly saturated fats, without adequate intake of polyunsaturated fat, may facilitate the development of obesity. The consumption of some specific foods including dried fruit (in a broad sense including walnuts, hazelnuts, almonds, cashews, etc.) within a reduced calorie diet is considered to be a promising approach in the prevention and care of the different components of the metabolic syndrome. The nuts and hazelnuts are rich in potentially beneficial substances including unsaturated fatty acids, especially omega-6 (present in both) and omega-3 (present only in nuts), L-arginine, fiber, minerals, vitamin E, fitosetrols and polyphenols. Several clinical trials have already shown in adults a potential beneficial effect of the addition of different types of nuts (walnuts, hazelnuts, cashews, pistachios, etc.) on the characteristics of the metabolic syndrome also through their possible antioxidant and vasoactive effect . In children, some epidemiological studies have associated a higher consumption of nuts with reduced risk of hypertension, dyslipidemia, obesity and fasting glucose alteration. Our group conducted a study in obese children observing an inverse relationship between omega-6 polyunsaturated fatty acids, contained in large amounts in walnuts, and certain features of metabolic syndrome, such as waist circumference, triglycerides, fasting insulin, systolic blood pressure of 24-hours, suggesting a possible beneficial effect. The project was financed by health ministry and included also the present Protocol ("Obesity, hypertension and subclinical vascular damage in children: the role of dietary factors and lipid mediators. An epidemiological and translational study. "Project Code: GR-2011-02349630). From arachidonic acid, the main omega-6 type polyunsaturated fatty acids (PUFA), certain metabolites are produced via cytochrome P450 which have vasoactive and natriuretic effect: 20-Hydroxyeicosatetraenoic acid (20-HETE), the epoxyeicosatrienoic acids (EETs) and dihydroxyeicosatrienoic acids (DHETs). From numerous studies in animal models and some human studies, it is known that these metabolites via cytochrome P450 may be involved both in the homeostasis of blood pressure pressure and in the development of hypertension. In particular, plasmatic 20-HETE has a vasoconstrictor effect while EETs are vasodilators; both exert renal natriuretic effect. Our study intends to verify if in a group of obese children, a low-calorie diet that contains a portion of walnuts and hazelnuts, can change the content of polyunsaturated fatty acids in erythrocyte membranes, particularly alpha-linolenic acid. This could result in possible beneficial effects on the characteristics of the metabolic syndrome in obese children, like an improvement of waist circumference, blood pressure, HDL cholesterol, triglycerides and blood sugar. Our study also intends to acquire information on the effect of the addition of walnuts and hazelnuts and the metabolites of polyunsaturated fatty acids omega-3 and omega-6 metabolized by cytochrome P450 that derives from these nuts in change vessel elasticity. 2. STUDY DESIGN The study will be conducted with a randomized design (two arms in parallel with blinded operator). Doctors in charge of vascular measurements and laboratory technicians will not know which of the two groups analyzed will only have taken the low-calorie diet and who will have assumed the low-calorie diet with walnuts and hazelnuts. 3. PURPOSE OF THE STUDY The main objective of this study is to assess the efficacy of 15 grams of nuts and 15 grams of nuts a day in addition to a low calorie diet, in modifying the content of of alpha-linolenic acid in erythrocyte membranes evalutated three months after the beginning of the assumption in a group of obese children. Secondary objectives are: To evaluate the efficacy of walnuts and hazelnuts in improving in obese children: - the systolic and/or diastolic blood pressure values; - metabolic disorders (in particular of the lipid profile: LDL, HDL, triglycerides, and glucose: glucose and fasting insulin); - vascular function measured by tonometry (PWV and PWA), and ultrasonography (carotid distensibility). - the modifications of the profile of eicosanoids via CYP450 in plasma and urine To evaluate: - the relationship between intake of nuts and hazelnuts, fatty acid profile of erythrocyte membranes and eicosanoids via CYP450, the components of the metabolic syndrome including the blood pressure and vascular elasticity.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date May 18, 2022
Est. primary completion date May 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - obese subjects (BMI = 95th percentile for age and sex; reference tables for WHO BMI); - Aged between 6 and 17 years; - Signature applied in the informed consent by both parents and consent of the child Exclusion Criteria: - chronic liver diseases (hepatitis, cirrhosis). - Chronic renal failure (serum creatinine> 1.2 mg / dL). - Malignancies. - Diabetes (fasting blood glucose = 126 mg / dl or therapy with oral hypoglycemic drugs or insulin). - cholesterol-lowering or antihypertensive terapy. - Notes allergies to nuts or hazelnuts or food intolerance to nuts and/or hazelnuts. - Treatment of less than 6 weeks with any medication which can interfere with fecal microbiota (particularly antibiotics or laxatives).

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
wNUTS, low-caloric diet plus nuts
15g of nuts and 15g of hazelnuts in association with low caloric diet
Other:
w/oNUTS, low-caloric diet without nuts
low caloric diet

Locations

Country Name City State
Italy AOUI Verona Verona VR

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary ALA change Primary outcome is to compare percentage of fatty acids in erythrocyte membranes (in particular alpha-linolenic acid, ALA) with the content of other membrane-bound fatty acids. It will be compared in the two groups the ALA delta (delta%) between measurement at baseline compared to post-treatment (ie, after 3 months of treatment). baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary LA change to compare percentage of fatty acids in erythrocyte membranes (in particular linoleic acid, LA) with the content of other membrane-bound fatty acids. It will be compared in the two groups the ALA delta (delta%) between measurement at baseline compared to post-treatment (ie, after 3 months of treatment). baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary ABPM change To compare ambulatory blood pressure (mmHg) measured by validated devices (A&D TM-2430; in the week preceding the beginning of the assumption of diet plus or minus nuts/hazelnuts) and after 3 months from randomization in the two arms. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary OFFICE BLOOD PRESSURE change To compare mean arterial pressure obtained during the medical examination (mmHg) by oscillometric validated device in children (Omron 705 IT; average of three measurements) prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary HDL-cholesterol change To compare HDL-cholesterol baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary triglycerides change To compare triglycerides baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary glucose change To compare plasma glucose baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary WAIST CIRCUMFERENCE change To compare waist circumference change in the 2 arms prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary WEIGHT change To compare weight change in the 2 arms prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary PWA (Augmentation Index; AIx) change To compare AIx change as measured by pulse wave analysis (PWA) by SphygmoCor XCEL and in the 2 arms prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary cfPWV change To compare carotid femoral pulse wave velocity (PWV) change measured by tonometer (SphygmoCor XCEL) in the 2 arms prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary carotid distensibility (cDC) change To compare cDC change measured by ultrasound in the 2 arms prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary plasma EETs change To compare plasma epoxyeicosatrienoic acids, metabolites of arachidonic acid vis CYP450 baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary plasma DHETs change To compare plasma dihydroxyeicosatrienoic acids, metabolites of EETs via sEH baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary urine DHETs change To compare urine dihydroxyeicosatrienoic acids, metabolites of EETs via sEH baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary plasma 20-HETE change To compare plasma 20-hydroxyeicosatetraenoic acids, metabolites of arachidonic acid via CYP450 baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary urine 20-HETE change To compare urine 20-hydroxyeicosatetraenoic acids, metabolites of arachidonic acid via CYP450 baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary plasma EEQs change To compare plasma epoxyeicosatetraenoic acids, metabolites of eicosapentaenoic acid via CYP450 baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary plasma EDPs change To compare plasma epoxydocosapentaenoic acids, metabolites of docosahexaenoic acid via CYP450 baseline compared to post-treatment (ie, after 3 months of treatment)
Secondary MICROBIOTA change To compare profile of the faecal microbiota by metagenomic of the gene sequences coding for the 16S rRNA prior to randomization and after 3 months of diet intake plus or minus nuts/hazelnuts. baseline compared to post-treatment (ie, after 3 months of treatment)
See also
  Status Clinical Trial Phase
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Enrolling by invitation NCT05166629 - Eatable Alphabet as a Nutrition Education Tool N/A
Recruiting NCT05140070 - Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A
Completed NCT04042467 - Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention N/A
Completed NCT01974102 - Family Based Mindfulness Intervention N/A
Recruiting NCT05403658 - Attrition in Pediatric Obesity Management N/A
Completed NCT04315220 - Corestability Training in Overweight Children N/A
Recruiting NCT05570396 - Long-term Follow-up on Childhood Adiposity - The FitKids Study
Recruiting NCT03643341 - Family Healthy Living Early Intervention Program N/A
Completed NCT03219658 - STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity N/A
Recruiting NCT05540678 - The FibreGum Study - Changing the Course of Obesity in Children N/A
Completed NCT04459130 - Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years N/A
Completed NCT05019339 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education N/A
Active, not recruiting NCT03950453 - Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention N/A
Completed NCT03982511 - Improving Parent-Child Interactions to Enhance Child Health N/A
Active, not recruiting NCT06317883 - Childhood Obesity Risk Assessment Longitudinal Study
Completed NCT02206529 - Enhancing Family Based Treatment of Childhood Obesity Through Social Networks N/A
Recruiting NCT06341179 - Effect of Sleep Extension on Overweight and Learning in Children N/A
Recruiting NCT04802291 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity N/A