Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects (CHOCO)
Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Lazio
-
Rome, Lazio, Italien, 00128
- Campus Bio-Medico University of Rome
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Healthy volunteers of both genders.
- Aged > 18 years.
- Body mass index ranging from 18 to 29.99 kg/m2.
- Subjects able to provide written informed consent.
Exclusion Criteria:
- Diagnosis of diabetes. defined as per the Italian Society of Diabetology guidelines. fasting glucose twice greater than 126 mg / dL and/or random glucose greater than 200 mg / dL.
- Subjects being treated with oral and/or injectable hypoglycemic and/or insulin-sensitizing agents
- Subjects undergoing therapy with synthetic cholesterol-lowering agents (statins and/or fibrates) and/or cholesterol-lowering nutraceuticals (berberine and/or monacolin k)
- Individuals with triglycerides greater than 200 mg/dL
- Subjects with LDL greater than 159 mg/dL
- Moderate or major renal impairment (and GFR <60 mL/min)
- Hypertensive subjects and/or subjects being treated with antihypertensives
- Subjects receiving omega 3 supplements.
- Pregnancy and/or breastfeeding.
- Coronary cardiovascular disease.
- Stroke and heart failure.
- Celiac disease.
- Malabsorption.
- Irritable bowel syndrome.
- Chronic inflammatory bowel disease.
- Present alcoholism or drug abuse or use of medicines whose dose may change during the study or when there is an intention to start a new therapy.
- Individuals with an allergy to hazelnuts or any of the ingredients present in the chocolates under study.
- Neurological or psychiatric pathologies
- Subjects who cannot participate in the study for any reason
- Infectious diseases such as HIV, hepatitis or chronic infections
- Any uncontrolled endocrine pathology such as Cushing's. Acromegaly. etc.
- Any existing cancer and/or lymphoma
- Eating disorders such as anorexia and bulimia
- Previous bariatric surgery or gastrectomy
- Individuals with pacemakers
- Not consuming the chocolate spread for more than three days
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Extra Virgin Olive Oil Group
Subjects will consume 100 grams of Extra Virgin Olive Oil-enriched chocolate spread for 14 days.
|
the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
|
|
Aktiver Komparator: Palm oil Group
Subjects will consume 100 grams of palm oil enriched chocolate spread for 14 days.
|
the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Plasma Ceramides
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Ceramides expressed in nmol
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
HOMA-IR calculated as ((fasting insulin (mU/mL) x fasting glucose (mg/dL))/405)
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Insulin
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Plasma Insulin reported in mU/mL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Glucose
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Plasma glucose reported in mg/dL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Low Density Lipoprotein (LDL)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting LDL reported in mg/dL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Triglycerides
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Triglycerides reported in mg/dL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Total Cholesterol
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Total Cholesterol reported in mg/dL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma High Density Lipoprotein (HDL)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting Plasma HDL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma C-reactive protein (CRP)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting CRP reported in mg/dL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Interleukin-6
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting interleukin-6 reported in pg/mL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Tumor Necrosis Factor-alpha (TNF-alpha)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Fasting TNF-alpha reported in pg/mL
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Glucagon Like Peptide-1 (GLP-1)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Oxyntomodulin
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Ghrelin
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Peptide YY (PYY)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Leptin
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Plasma Adiponectin
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
|
Visual Analogue Scale (VAS)
Zeitfenster: At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
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.
|
At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Professor Silvia Manfrini, MD, Campus Bio-Medico University of Rome
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CHOCO study
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .