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Functional effect on cardiovascular and neurological health of Passiflora setacea passion fruit species in overweight sedentary individuals

Leukocyte gene expression response, monocyte adhesion, neuronal response and metabolite excretion in healthy individuals after Passiflora setacea pulp consumption: a nutrigenomic, metabolomic and in vitro approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-84z83n
Enrollment
Unknown
Registered
2019-10-23
Start date
2015-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular diseases

Interventions

The 12 participants signed a Free and Informed Consent Form (ICF), in which information on research was described, including the guarantee of indemnity if something happens to the volunteer's health.
anthropometric: weight, height and waist circumference
clinical: blood pressure) and t3h (biochemical: glucose). and total triglycerides). The biological samples were collected from the volunteers by the Sabin partner laborator
Dietary supplement

Sponsors

Universidade de Brasília
Lead Sponsor
INRA - Institut National de la Recherche Agronomique
Collaborator
Embrapa Cerrados
Collaborator

Eligibility

Sex/Gender
Male
Age
40 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy subjects; males; aged between 40 and 64 years; overweight (BMI between 25 and 30 kg/m2 or waist circumference greater than 94cm).

Exclusion criteria

Exclusion criteria: Smokers; practitioners of physical activity over 5h per week; passion fruit allergic and fruit-based products; supplement users in the two months prior to the experiment (vitamin C, multivitamins, antioxidant capsules, etc.); medication users for chronic treatments (antihypertensive, antihyperglycemic, anticholesterol, antidepressant, sleep aid, anxiolytic, etc.), acute treatments in the 15 days prior to the experiment (potent anti-inflammatories, antibiotics, etc.); acute treatments in the two days prior to the experiment ( anti-inflammatory pain relievers such as aspirin, acetaminophen, etc.).

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: To evaluate the effect of Passiflora setacea juice on the modulation of certain inflammatory biochemical markers (glucose, triglycerides, HDL, PCR) by collecting blood from volunteers before and after each intervention.;Expected Outcome 2: To evaluate the effect of Passiflora setacea juice on modulation of certain immunological markers (pro and anti-inflammatory cytokines) in blood samples from volunteers by flow cytometry (CBA HUMAN TH1, TH2, TH17 Kit).;Expected Outcome 3: To evaluate the effect of Passiflora setacea juice on the modulation of the gene expression profile of the markers previously mentioned by microarray technique.

Secondary

MeasureTime frame
Outcome 1: Significant reduction in serum glucose and insulin concentrations after Passiflora setacea juice consumption.;Outcome 2: Significant reduction in serum IL-17A concentrations after Passiflora setacea juice consumption.;Outcome 3: Significantly reduced expression of 1327 genes associated with inflammation, metabolism, cell signaling, and neuronal function.

Countries

Brazil

Contacts

Public ContactAna ;Isabella Costa;de Araújo Esteves Duarte

Embrapa Cerrados;Universidade de Brasília

ana-maria.costa@embrapa.br;duarte.isabella07@gmail.com+556133889804;+5561999968004

Outcome results

None listed

Source: REBEC (via WHO ICTRP)