Evidence mapPaperPMID 39940271Full record

Trial reportNutrients2025

The Effects of a Food Supplement, Based on Co-Micronized Palmitoylethanolamide (PEA)-Rutin and Hydroxytyrosol, in Metabolic Syndrome Patients: Preliminary Results.

Kevin Cornali, Manuela Di Lauro, Giulia Marrone, Claudia Masci, Giulia Montalto, Alfredo Giovannelli, Carlo Schievano, Manfredi Tesauro, Massimo Pieri, Sergio Bernardini and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Palmitoylethanolamide in Human and Animal Obesity.Molecules (Basel, Switzerland) · 2026
    Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kevin CornaliDepartment of Experimental Medicine, PhD School in Biochemistry and Molecular Biology, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0009-0004-8904-4399
Manuela Di LauroDepartment of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0000-0001-8118-1330
Giulia MarroneDepartment of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0000-0002-5854-2086
Claudia MasciDepartment of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.
Giulia MontaltoSchool of Specialization in Nephrology, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0009-0004-3501-6894
Alfredo GiovannelliUnit of Laboratory Medicine, University Hospital Tor Vergata, 00133 Rome, Italy.
Carlo SchievanoInnovative Statistical Research, 35100 Padua, Italy.ORCID 0000-0001-7176-1980
Manfredi TesauroDepartment of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.
Massimo PieriUnit of Laboratory Medicine, University Hospital Tor Vergata, 00133 Rome, Italy.ORCID 0000-0002-3463-0268
Sergio BernardiniUnit of Laboratory Medicine, University Hospital Tor Vergata, 00133 Rome, Italy.
Annalisa NoceDepartment of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0000-0003-1310-3730

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetabolic syndrome (MetS) patients have impaired hypothalamic regulatory functions involved in food intake and energy expenditure and suffer from a state of meta-inflammation. Pre-clinical studies demonstrated that ultramicronized palmitoylethanolamide (PEA) acts both on the adipose tissue and the central nervous system, while hydroxytyrosol (HTyr) counteracts several types of dysmetabolism.

objectivesThe aim of our randomized crossover double-blind placebo-controlled pilot study was to evaluate the potential effects of a food supplement (FS) containing a co-micronized formulation of PEA and rutin along with HTyr, combined with a tailored calorie-controlled Mediterranean diet, in patients with MetS.

methodsNineteen patients were enrolled and block-randomized to an eight-week MD together with the FS or placebo. After a two-week washout period, the treatments were reversed. Data on laboratory parameters and those detected by capillary sampling, anthropometry, body composition analysis, ultrasound examination, blood pressure monitoring, the 36-Item Short-Form Health Survey questionnaire, handgrip strength test, and physical performance tests were collected at each time point (protocol code R.S. 262.22, registered on 20 December 2022).

resultsAt the end of the study, patients supplemented with the FS showed a significant reduction in body weight, body mass index, fat mass, and inflammation biomarkers (CRP and ESR), compared to placebo-supplemented patients. In contrast, the fat-free mass, phase angle, and body cell mass were increased in FS compared to placebo patients.

conclusionsAlthough preliminary, the results of our clinical study suggest that co-micronized PEA-rutin and HTyr may be of help against adiposopathy in patients with MetS.

Indexed as

AmidesDietary SupplementsEthanolaminesMetabolic SyndromePalmitic AcidsPhenylethyl AlcoholAdultAgedCross-Over StudiesDiet, MediterraneanDouble-Blind MethodFemaleHumansMaleMiddle AgedPilot Projects3,4-dihydroxyphenylethanolAmidesEthanolaminespalmidrolPalmitic AcidsPhenylethyl Alcoholadiposopathybody composition assessmentco-micronized palmitoylethanolamidehydroxytyrosolmediterranean dietmetabolic syndromemeta-inflammationnatural bioactive compoundsrutin

Identifiers

PMID39940271
PMCPMC11820307

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.