NCT03524742: ADD-SPISE

Effects of an Avocado Based meDiterranean Diet on Serum Lipids for Secondary Prevention After Ischemic StrokE Trial. Study Protocol.

Completed NA Last updated 15 August 2023

What this trial tests

NA trial testing Avocado-Mediterranean Diet in Stroke, Acute in 200 participants. Completed in 19 January 2023.

Timeline

16 August 2018

Primary endpoint
19 January 2023

19 January 2023

Quick facts

Lead sponsor	Clinica Alemana de Santiago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	200
Start date	16 August 2018
Primary completion	19 January 2023
Estimated completion	19 January 2023
Sites	1 location across Chile

Drugs / interventions tested

• Avocado-Mediterranean Diet
• Control-Group Diet

Conditions studied

• Stroke, Acute — all drugs for Stroke, Acute →
• Stroke, Ischemic — all drugs for Stroke, Ischemic →

Sponsor

Clinica Alemana de Santiago

Who can join

45 and older, any sex, with Stroke, Acute or Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent global burden of disease analysis of DALYs, showed that dietary risk have the highest DALYs in ischemic stroke among behavioral risk factors. The MediDiet is associated with a decreased risk of total mortality as well as stroke incidence and mortality. Although not part of the classical Mediterranean diet they are another nutrient-dense source of MUFA, rich in vitamins, minerals, fiber, phytosterols and polyphenols extensively consumed in the Americas. Avocado-substituted diets significantly decrease cholesterol levels in diabetic and obese patients. Secondary stroke prevention studies with diet as an intervention are lacking and there is little information of what patients eat before or after an ischemic stroke. Lowering Low Density Cholesterol (LDL-C) levels decreases stroke recurrence. The aim is to determine the effect of a Mediterranean style diet based on Avocados on lipid profile particularly LDL-C in patients who have had an ischemic stroke and are at high recurrence risk.Methodology: Academic, open-label, blinded outcome assessment (PROBE design), clinical trial. Participants will be patients with an acute ischemic stroke admitted to Clínica Alemana de Santiago, who fulfills the eligibility criteria. Eligible patients will be randomly assigned to either diet intervention in a 1:1 ratio. The interventions will be: A) Avocado based Mediterranean diet with intake of ½ portion of a Hass avocado per day and B) Standard recommendation of low fat-high complex carbohydrate diet recommended by the National Cholesterol Education Program and the American Heart Association. The main efficacy outcome will be the level of plasma LDL-C level at 3 months of the dietary intervention. Secondary outcomes will be changes in: Levels of serum lipid profile, serum inflammation markers, glycemic control, anthropomorphic measures, stroke recurrence, cardiovascular events, adverse events, compliance. A sample size of 100 patients per group (200 in total) was estimated to provide 80% power and 5% level of significance with 10% loss and 5% crossover to detect the same difference in LDL-C after 3 months of intervention in patients with acute stroke. The investigators hypothesize that an Avocado based Mediterranean diet will significantly reduce levels of LDL-cholesterol at 3 months in patients who have suffered a recent acute ischemic stroke compared to the standard diet.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Introducing Plant-Based Mediterranean Diet as a Lifestyle Medicine Approach in Latin America: Opportunities Within the Chilean Context.
   Figueroa C, Echeverría G, Villarreal G, Martínez X, et al · · 2021 · cited 22× · PMID 34249989 · DOI 10.3389/fnut.2021.680452
2. Mediterranean Lifestyle to Promote Physical, Mental, and Environmental Health: The Case of Chile.
   Echeverría G, Tiboni O, Berkowitz L, Pinto V, et al · · 2020 · cited 18× · PMID 33207718 · DOI 10.3390/ijerph17228482
3. Late Breaking Abstracts.
   · 2021 · cited 10× · PMID 35252583 · DOI 10.1177/23969873211044666
4. Efficacy of an avocado-based Mediterranean diet on serum lipids for secondary prevention after ischemic stroke: a randomized phase 2 controlled pilot trial.
   Olavarría VV, Campodónico PR, Vollrath V, von Geldern P, et al · · 2025 · cited 4× · PMID 39905430 · DOI 10.1186/s12944-025-02454-4
5. Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol.
   Olavarría VV, Campodónico P, Vollrath V, von Geldern P, et al · · 2021 · cited 4× · PMID 34128908 · DOI 10.1097/md.0000000000026425
6. E-Poster Viewing – Miscellaneous
   · 2019