Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2016
Date assigned
10/06/2016
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Regular intake of nuts, naturally rich in monounsaturated fats (MUFA) or other polyunsaturated (PUFA) sources may reduce the risk of developing cardiovascular disease (CVD) and also improve lipid profile (fats and cholesterol in the blood). People with a high level of serum lipids (that is, a lot of fat in the blood) seem to be more susceptible to oxidative stress (damage caused by free radicals) and CVD. They may therefore benefit from an increased nut or MUFA and PUFA intake. The aim of this study was to investigate the effect of hazelnuts eaten as snack or source of polyunsaturated fats (e.g. alpha-linolenic acid) on markers of oxidative stress (that is, substances that show the presence of oxidative stress), inflammation, lipid profile, dietary markers and intestinal microflora (microbiota) composition in children and adolescents with dyslipidemia (abnormal amounts of fat in the blood)

Who can participate?
Children aged between 5-17 years with dyslipidemia.

What does the study involve?
At the beginning of the study, all participants are given dietary guidelines and are randomly allocated to one of three groups. One group eat a daily portion of hazelnuts with skin (15-30 g/Kg, based on body weight), one group eat the same amount of hazelnuts without skin and a control group receive only the dietary guidelines and are not given nuts to eat or a diet otherwise enriched with other sources of unsaturated fats.Blood samples are taken for all participants from all groups at the start of the study and then 8 weeks later for analysis.

What are the possible benefits and risks of participating?
The intake of hazelnuts as a snack is expected to improve the lipid profile and reduce the levels of oxidative stress in children and adolescents with dyslipidemia. There is are expected risks associated with the eating of the hazelnuts.

Where is the study run from?
The University of Turin and University of Milan (Italy)

When is the study starting and how long is it expected to run for?
January 2015 to December 2016

Who is funding the study?
The European Regional Development Fund

Who is the main contact?
1. Professor Patrizia Riso (scientific)
patrizia.riso@unimi.it
2. Professor Ornella Guardamagna (scientific)
ornella.guardamagna@unito.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Patrizia Riso

ORCID ID

http://orcid.org/0000-0002-9204-7257

Contact details

Università degli Studi di Milano
Via Celoria 2
Milano
20133
Italy
+390250316726
patrizia.riso@unimi.it

Type

Scientific

Additional contact

Prof Ornella Guardamagna

ORCID ID

Contact details

Università degli Studi di Torino
Piazza Polonia 94
Torino
10126
Italy
+390113135243
ornella.guardamagna@unito.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number: EC:CS377

Study information

Scientific title

Effect of hazelnut or polyunsaturated fat intake on oxidative stress related markers and lipid profile in children and adolescents with primary dyslipidemia

Acronym

NO-OX Stress

Study hypothesis

Dyslipidemia is a major risk factor for cardiovascular disease development and it is closely associated with a decrease of antioxidant defense mechanisms. Nuts are rich sources of bioactives such as monounsaturated and polyunsaturated fatty acids, vitamins, phytosterols and polyphenols. We hypothesized that regular consumption of hazelnuts or other polyunsaturated sources (e.g. alpha-linolenic acid) could have a beneficial effect on dyslipidemia improving lipid profile and cell protection against oxidative DNA damage. Moreover, dietary interventions with polyunsaturated fats could also affect microbiota composition and inflammatory conditions eventually associated to dyslipidemia.

Ethics approval

Ethics Committee of the City of Health and Science University Hospital of Turin, 22/01/2015, ref: EC:CS377

Study design

8-week randomized, controlled, parallel, single-blind dietary intervention study

Primary study design

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Familiar dyslipidemia

Intervention

The study is an 8-week randomized, controlled, parallel, single-blind dietary intervention study. Subjects receive dietary guidelines and individually randomized to the following three parallel groups of 20 subjects each:

Group 1: Children consuming hazelnuts with skin as snack (between 15-30 g per day, based on body weight)
Group 2: Children consuming hazelnuts without skin as snack (between 15-30 g per day, based on body weight)
Group 3: Children who do not consume nuts (or children consuming other sources of unsaturated fats)

At the beginning and at the end of the intervention (t= 8 weeks), blood and stool samples are collected and used to evaluate the oxidative stress related markers (e.g. DNA damage, oxidized LDL, PON-1 concentration, etc.), the serum lipid profile and erythrocyte membrane phospholipids composition. In addition, dietary and metabolic markers (e.g. microbiota composition, inflammatory related markers, etc.) are analysed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Endogenous oxidized DNA bases (using enzyme formamidopyrimidine-DNA glycosylase) measured by Comet assay in peripheral blood mononuclear cells at baseline (t=0) and at the end of intervention (t=8 weeks)

Secondary outcome measures

1. Changes in serum lipid profile triglycerides, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol
2. Changes in erythrocyte phospholipids composition
3. Changes in anthropometric characteristics (age, weight, height, body mass index)
4. Changes in blood pressure (diastolic and systolic blood pressure)
5. Changes in oxidized LDL and paraoxonase 1 (PON-1)
6. Changes in markers of inflammation
7. Changes in microbiota composition

All assessed at baseline and at the end of intervention (8 weeks)

Overall trial start date

01/01/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 5-17 years affected by primary dyslipidemia (familiar hypercholesterolemia, familiar combined hyperlipidemia and undefined hypercholesterolemia),
2. Total cholesterol and/or triglycerides value higher than their age- and sex-specific 90th percentile
3. Body mass index (BMI) <95th percentile

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60 children/adolescents

Participant exclusion criteria

1. Secondary dyslipidemias, overweight or obesity (BMI ≥ 85th and ≥ 95th percentile, age and sex matched, respectively)
2. Children under lipid-lowering treatment (including functional foods) from the 3 months before the beginning of the study
3. History of renal, endocrine, liver disorders, or chronic diseases (i.e., immunologic, neurologic, or oncohematologic disorders)
4. Smokers
5. Use of any drugs, supplements, specific prebiotics or probiotics or medications at least one month before the beginning of the experiment.
6. Subjects with specific aversion or allergies to food under study

Recruitment start date

01/01/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Italy

Trial participating centre

University of Turin (Università degli Studi di Torino)
Department of Health, Sciences and Pediatric Piazza Polonia 94
Torino
10126
Italy

Trial participating centre

University of Milan (Università degli Studi di Milano)
Department of Food, Environmental and Nutritional Sciences Division of Human Nutrition Via Celoria 2
Milano
20133
Italy

Sponsor information

Organisation

Regione Piemonte

Sponsor details

Piazza Castello 165
Torino
10123
Italy

Sponsor type

Other

Website

http://www.regione.piemonte.it/industria/

Funders

Funder type

Not defined

Funder name

The European Regional Development Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

31/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes