Protective role of dietary intervention rich in unsaturated fats in dyslipidemic children
| ISRCTN | ISRCTN12261900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12261900 |
| Protocol serial number | Protocol number: EC:CS377 |
| Sponsor | Regione Piemonte |
| Funder | European Regional Development Fund |
- Submission date
- 27/04/2016
- Registration date
- 10/06/2016
- Last edited
- 14/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 is 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 5-17 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. Prof. Patrizia Riso (scientific)
patrizia.riso@unimi.it
2. Prof. Ornella Guardamagna (scientific)
ornella.guardamagna@unito.it
Contact information
Scientific
Università degli Studi di Milano, Via Celoria 2
Milano
20133
Italy
 ORCID ID |
0000-0002-9204-7257 |
|---|---|
| Phone | +39 (0)250 316 726 |
| patrizia.riso@unimi.it |
Scientific
Università degli Studi di Torino, Piazza Polonia 94
Torino
10126
Italy
| Phone | +39 (0)113 135 243 |
|---|---|
| ornella.guardamagna@unito.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 8-week randomized controlled parallel single-blind dietary intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of hazelnut or polyunsaturated fat intake on oxidative stress related markers and lipid profile in children and adolescents with primary dyslipidemia |
| Study acronym | NO-OX Stress |
| Study objectives | 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(s) | Ethics Committee of the City of Health and Science University Hospital of Turin, 22/01/2015, ref: EC:CS377 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
1. Changes in serum lipid profile triglycerides, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Italy
Study participating centres
Piazza Polonia 94
Torino
10126
Italy
Via Celoria 2
Milano
20133
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2018 | Yes | No | |
| Results article | results | 01/08/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/05/2018: Publication reference added.
14/06/2017: Publication reference added.
