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Crossover study of diets enriched with virgin olive oil, walnuts or almonds. Effects on lipids and other cardiovascular risk markers

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68210440
Enrollment
20
Registered
2010-12-14
Start date
2007-01-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Nutritional, Metabolic, Endocrine

Interventions

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

Sponsors

International Nut and Dried Fruit Foundation (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
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

Primary

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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026