An interventional study of Extra Virgin Olive Oil-enriched chocolate spread and Palm Oil-enriched chocolate spread in Healthy Diet, sponsored by Campus Bio-Medico University. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Campus Bio-Medico University · Not applicable, Interventional, and Treatment
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.
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.
Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will consume 100 grams of Extra Virgin Olive Oil-enriched chocolate spread for 14 days.
Dietary Supplement: Extra Virgin Olive Oil-enriched chocolate spread
Subjects will consume 100 grams of palm oil enriched chocolate spread for 14 days.
Dietary Supplement: Palm Oil-enriched chocolate spread
the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.
Plasma Ceramides
Fasting Ceramides expressed in nmol
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
HOMA-IR calculated as ((fasting insulin (mU/mL) x fasting glucose (mg/dL))/405)
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Insulin
Fasting Plasma Insulin reported in mU/mL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Glucose
Fasting Plasma glucose reported in mg/dL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Low Density Lipoprotein (LDL)
Fasting LDL reported in mg/dL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Triglycerides
Fasting Triglycerides reported in mg/dL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Total Cholesterol
Fasting Total Cholesterol reported in mg/dL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma High Density Lipoprotein (HDL)
Fasting Plasma HDL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma C-reactive protein (CRP)
Fasting CRP reported in mg/dL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Interleukin-6
Fasting interleukin-6 reported in pg/mL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Tumor Necrosis Factor-alpha (TNF-alpha)
Fasting TNF-alpha reported in pg/mL
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Glucagon Like Peptide-1 (GLP-1)
GLP-1 Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Oxyntomodulin
Oxyntomodulin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Ghrelin
Ghrelin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Peptide YY (PYY)
PYY Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Leptin
Leptin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plasma Adiponectin
Adiponectin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Visual Analogue Scale (VAS)
VAS Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in mm\*min.
Time frame: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
Plan to share: No
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