An interventional study of High quality extra virgin olive oil in Obesity, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Prevention
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Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, [1]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity [2]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD [3,4].
Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
This study's enrollment of 36 is below the median of 67 across 9,016 interventional studies indexed under Obesity.
Browse Obesity studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: High quality extra virgin olive oil
Other: High quality extra virgin olive oil
Cases and controls were given 40 g/die high quality extra virgin olive oil
anti-inflammatory cytokines
Time frame: Time 0 (T0)
changes in anti-inflammatory cytokines
Time frame: after 3 months from T0 (T1)
No study locations are listed for this record.
Ran from Jan 2014 to primary completion in Jun 2016, 28 months.
Of 3,685 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 28 months is above that.
Counting every sponsor, half of 3,848 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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