Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/11/2010
Date assigned
14/12/2010
Last edited
14/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emilio Ros

ORCID ID

Contact details

Hospital Clínic de Barcelona
C/ Villarroel 170
Barcelona
08036
Spain
+34 (0)93 2279383
eros@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INC0706

Study information

Scientific title

Effects of diets enriched with virgin olive oil, walnuts or almonds on lipids and other cardiovascular risk markers: a randomised crossover study

Acronym

ONA

Study hypothesis

Virgin olive oil and nuts are basic components of the Mediterranean diet, a heart-healthy dietary pattern. Nuts have well known cholesterol lowering effects, while evidence is unclear for virgin olive oil. We designed a study in hypercholesterolemic patients to assess the effects on serum lipids and other intermediate markers of cardiovascular risk of replacing 40% of the fat in the background diet with virgin olive oil, walnuts or almonds. Our hypothesis is that daily intake of virgin olive oil will be associated with low density lipoprotein (LDL) cholesterol lowering to a similar extent than walnuts and almonds consumed at similar doses as percent of total energy.

Ethics approval

The Institutional Review Board of the Hospital Clínic of Barcelona approved on the 21st March 2006 (ref: CEIC 3110-2006)

Study design

Randomised crossover nutrional intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Nutrition

Intervention

In participants following a background Mediterranean-type isocaloric diet with similar energy, total fat and saturated fat content will be allocated to 3 random sequential periods lasting 4 weeks each in which 40% of energy (25% of fat) is replaced by virgin olive oil, walnuts or almonds.
1. Virgin olive oil is provided in 0.5 litre units sufficient to cover daily allowances of 35 to 50 g, depending on total energy requirements
2. Raw, shelled Spanish almonds (Marcona variety) provided in pre-packaged daily allowances from 50 to 75 g (almonds)
3. Spanish-grown walnuts (Serr/Chandler variety) from 40 to 65 g

No washout necessary between arms because after a dietary intervention is terminated serum lipid changes stabilise in less than 3 weeks. Duration of the study for all participants is 16 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effects of the three diets on the serum lipid profile, with LDL cholesterol changes from baseline

Secondary outcome measures

1. Medical records, including anthropometric measurements (height, weight and waist circumference) and blood pressure at baseline and end of each diet period
2. Food, energy and nutrient intake assessed by 7-day food records at the end of each diet period
3. Plasma fatty acid proportions (as objective measure of compliance); concentrations of noncholesterol sterols, high-sensitivity C-reactive protein, homocysteine, oxidized LDL, ICAM-1, and VCAM-1; and in vitro LDL oxidizability assay to determine lag time of conjugated diene formation at baseline and end of each diet period

Overall trial start date

10/01/2007

Overall trial end date

15/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asymptomatic men and women with moderate hypercholesterolemia, age 25 to 75 years (after menopause in women)
2. Serum LDL cholesterol more than 3.36 mmol/L
3. Triglycerides less than 2.82 mmol/L
4. Absence of chronic illnesses or secondary hypercholesterolemia
5. No known allergy to nuts
6. Participants can be under stable lipid-lowering drug treatment (statins or fibrates, statins at doses of no more than simvastatin 40 mg/day or equivalent)
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Subjects on a weight-losing diet
2. Familial hypercholesterolemia
3. Established type 2 diabetes
4. Fatty food intolerance
5. Consumption of products that can influence cholesterol metabolism (other than statins and fibrates), such as resins, ezetimibe, psyllium, fish oil concentrates, soy lecithin, or phytoestrogens

Recruitment start date

10/01/2007

Recruitment end date

15/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clínic de Barcelona
Barcelona
08036
Spain

Sponsor information

Organisation

International Nut and Dried Fruit Foundation (Spain)

Sponsor details

c/o Ms. Goretti Guasch
C. Boule 2
4
Reus
43201
Spain
+34 (0)977 331 416
inc@nutfruit.org

Sponsor type

Research organisation

Website

http://www.nutfruit.org

Funders

Funder type

Research organisation

Funder name

International Nut and Dried Fruit Foundation (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Ministry of Science and Innovation (Spain) - Instituto de Salud Carlos III (CIBER Fisiopatología de la Obesidad y Nutrición [CIBERobn])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes