Status:
COMPLETED
Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Healthy Diet
Eligibility:
All Genders
18+ years
Phase:
NA
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 subje...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04917991
Start Date
May 2 2019
End Date
December 20 2019
Last Update
June 10 2021
Active Locations (1)
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1
Campus Bio-Medico University of Rome
Rome, Lazio, Italy, 00128