Efficacy of Nuts in Obese Children.

NCT03870984 | Terminated

• 1 other identifier: VRINoci
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Obesity

Keywords

obesity, children, nuts,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• LA change

  baseline compared to post-treatment (ie, after 3 months of treatment)

• ABPM change

  baseline compared to post-treatment (ie, after 3 months of treatment)

• OFFICE BLOOD PRESSURE change

  baseline compared to post-treatment (ie, after 3 months of treatment)

• HDL-cholesterol change

  baseline compared to post-treatment (ie, after 3 months of treatment)

• triglycerides change

  baseline compared to post-treatment (ie, after 3 months of treatment)

Study Arms (2)

wNUTS, low-caloric diet plus nuts

EXPERIMENTAL

low-caloric diet personalized on single children's requirements plus nuts (15g hazelnuts+15g nuts without shell) for 3 months.

Dietary Supplement: wNUTS, low-caloric diet plus nuts; Other: w/oNUTS, low-caloric diet without nuts

w/oNUTS, low-caloric diet without nuts

OTHER

low-caloric diet personalized on single children's requirements plus nuts (15g hazelnuts+15g nuts without shell) for 3 months.

Other: w/oNUTS, low-caloric diet without nuts

Interventions

wNUTS, low-caloric diet plus nuts DIETARY_SUPPLEMENT

15g of nuts and 15g of hazelnuts in association with low caloric diet

wNUTS, low-caloric diet plus nuts

w/oNUTS, low-caloric diet without nuts OTHER

low caloric diet

w/oNUTS, low-caloric diet without nuts; wNUTS, low-caloric diet plus nuts

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

AOUI Verona

Verona, VR, 37134, Italy

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Caloric Restriction; Nuts

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food; Food and Beverages

Study Officials

• Cristiano Fava, professor

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized design. Two arms in parallel with blinded operator.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 12, 2019
• Study Start: March 19, 2019
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

IT (1)