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NCT03669692WITHDRAWNanonymous

Open Randomized Clinical Trial to Evaluate the Effects of Intermittent Caloric Restriction in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Sponsor

Source record

Complexo Hospitalario Universitario de A Coruña

Phase

Source record

NA

Modality

AI-normalized

behavioral intervention

Target

AI-normalized

Caloric Restriction, Control

Indication / condition

AI-normalized

Prostatic Hyperplasia, Benign

Intervention

Source record

Caloric Restriction, Control

Source & freshness

Source record

NCT ID

NCT03669692

Original source

ClinicalTrials.gov

Source last updated

Aug 02, 2021

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03669692

Title

Open Randomized Clinical Trial to Evaluate the Effects of Intermittent Caloric Restriction in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Status

WITHDRAWN

Phase

NA

Condition raw

Prostatic Hyperplasia, Benign, Metabolic Syndrome

Condition normalized

Prostatic Hyperplasia, Benign, Metabolic Syndrome

Modality raw

behavioral intervention

Modality normalized

behavioral intervention

Target raw

Caloric Restriction, Control

Target normalized

Caloric Restriction, Control

Interventions

Caloric Restriction, Control

Public preview

Source record

Lower urinary tract symptoms (LUTS) include filling, emptying or post-voiding state alterations; producing symptomatology depending of the underline mechanism. Benign prostatic hyperplasia (BPH) is the most common underlying disease, which increases with age and significantly affects men over 50 years. There are currently no prevention or curative treatment guidelines, as their pathophysiological mechanism is not exactly known. Several factors have been implicated, such as hormones, aging, lifestyle or diet.

BPH is associated with metabolic disorders, the basis of which is insulin resistance and its associated pathologies: diabetes, hypertension, obesity, dyslipidemia and metabolic syndrome. Patients without these metabolic signs have a lower incidence of BPH and / or LUTS. Insulin resistance (IR) is associated with greater proliferation and a reduction of cellular apoptosis at the prostate level; leading to an increase in prostate volume or symptoms. Likewise, the autonomic nervous system (ANS) imbalance, both in favor of sympathetic (emptying symptoms) or parasympathetic (filling symptoms), influences LUTS. SNA activity can be measured non-invasively, repetitively and effectively by measuring the heart rate variability (HRV).

Caloric restriction with optimal nutrition (CRON, hereinafter only CR) is the most physiologically adapted nutritional alternative to our ancestral needs and has been shown in humans to reduce insulin resistance and associated pathologies. It has also been observed that CR improves the balance of the SNA and allows to improve LUTS.

Proliferation inhibition and prostatic apoptosis induction, mediated through CR, by insulin-IGF-1 axis reduction and mTOR metabolic pathways inhibition, are the central axis of this project. CR will be used to reduce insulin resistance, IGF expression and inhibition of the PI3K / AKT / mTOR pathway, to reduce prostate cell proliferation and promote prostatic tissue apoptosis; in this way it will be possible to reduce its volume and improve the symptomatology.

Additionally, CR will allow us to evaluate the potential benefits it has on certain metabolic diseases (diabetes, dyslipidemia, obesity, hypertension, etc.), anthropometric values (BMI, abdominal perimeter and skin folds) and autonomic nervous system functionality (HRV) .

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