NCT04917991

Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects

Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects: a Randomized, Double-blind, Cross-over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to investigate if extra virgin olive oil (EVOO) or palm oil enriched chocolate spread snacks consumption lead to differential insulin resistance status in young, healthy subjects. Such effect includes difference in a) plasma ceramides, b) glucose metabolism markers, c) lipid profile, d) inflammatory markers, e) hunger/satiety hormonal markers and visual analogue scale.

Detailed description

Exceeding intake of foods high in palmitic acid, abundant in Palm Oil, has been associated with lipotoxicity, a condition featured by high toxic lipids in the body such as ceramides, which ultimately can lead to insulin resistance and therefore to diabetes and increased cardiometabolic risk through the promotion of atheroma plaque formation. On the other hand, foods high in oleic acid, rich in extra virgin olive oil EVOO and typical of the Mediterranean diet, has been related to reduced insulin resistance and inflammatory state, with proved protective effects against metabolic diseases such as diabetes, hypercholesterolemia and cardiovascular disease. Therefore, this clinical trial aims to assess potential metabolic differences in relation to daily consumption of EVOO-enriched chocolate spread in comparison with a Palm oil-enriched chocolate spread. The investigators, therefore, aimed to evaluate the impact of fourteen days consuming the two different oils added to the same chocolate spread in terms of the composition of plasma ceramides as the primary outcome; and as secondary outcomes, changes in glucose metabolism markers (Glucose, Insulin, HOMA-IR), in LDL, total cholesterol, Triglycerides, HDL levels, in inflammation Markers (CRP, IL-6, TNF-a) and in the appetite-regulating hormones (Leptin, Adiponectin, GLP-1, Ghrelin, PYY and Oxyntomodulin) and in the visual analogue scale (VAS) analysis. Both chocolate spreads have an identical composition with the exception of fat content (EVOO vs. Palm Oil). Once eligibility will be assessed through screening and medical anamnesis, twenty healthy subjects will be enrolled and randomized based on a double-blind, controlled, crossover design. They will undergo a 1-week "run-in diet" phase before the randomization (V1) and the inception of a 14-day interventional diet phase 1. A compliance visit (V2) will be performed on day-7 to ensure that daily compliance is available from each participant (i.e., that the chocolate spread provided is eaten daily). On day 14, the participants will undergo a meal Challenge (V3), consuming the chocolate spread jar (challenge meal) and, serial blood withdrawals will be performed at times 0 ', 30', 60 ', 90', 120 'and 180 ' and, at the same time points, subjects will be required to complete a Visual Analogue Scale (VAS) for monitoring hunger and satiety. Subsequently, the subjects will undergo another week of run-in diet, identical to the previous run-in diet, to be then allocated to another fourteen days of the opposite treatment to the previous one, with the same described methods. Also, in all the visits physical examination with the collection of anthropometric data and body composition analysis will be performed. Study subjects will be provided structured meals, according to isocaloric diets designed by nutritionists based on subjects' energy requirements. Meals will be prepared by specific canteens and consumed on-site or collected daily in individual meal boxes. Patients will be asked to fill daily food diaries, in order to ensure all of the daily food is ingested (including the chocolate spread), as well as to assess any leftovers.

Conditions

• Healthy Diet

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extra Virgin Olive Oil-enriched chocolate spread	the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
DIETARY_SUPPLEMENT	Palm Oil-enriched chocolate spread	the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.

Timeline

• Start date: 2019-05-02
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2021-06-08
• Last updated: 2021-06-10

Locations

1 site across 1 country: Italy