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

NCT04917991 | Completed

• 1 other identifier: CHOCO study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Diet

Keywords

Ceramides; insulin resistance; lipids; Visual Analogue Scale; appetite; inflammation

Outcome Measures

Primary Outcomes (1)

• Plasma Ceramides

  Fasting Ceramides expressed in nmol

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

Secondary Outcomes (17)

• Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

• Plasma Insulin

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

• Plasma Glucose

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

• Plasma Low Density Lipoprotein (LDL)

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

• Plasma Triglycerides

  At the end of the dietary interventional phase (each dietary interventional phase is 14 days)

Study Arms (2)

Extra Virgin Olive Oil Group

EXPERIMENTAL

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

Palm oil Group

ACTIVE COMPARATOR

Subjects will consume 100 grams of palm oil enriched chocolate spread for 14 days.

Dietary Supplement: Palm Oil-enriched chocolate spread

Interventions

Extra Virgin Olive Oil-enriched chocolate spread DIETARY_SUPPLEMENT

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

Extra Virgin Olive Oil Group

Palm Oil-enriched chocolate spread DIETARY_SUPPLEMENT

the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.

Palm oil Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1:1 ratio for the 20 participants enrolled
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-Medico University of Rome

Rome, Lazio, 00128, Italy

Location

MeSH Terms

Conditions

Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Silvia Manfrini, MD

  Campus Bio-Medico University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Metabolic Diseases Unit

Model Details: Following eligibility assessment, the participants will be be randomized based on a double-blind crossover design.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 8, 2021
• Study Start: May 2, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)