- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669692
Open Randomized Clinical Trial to Evaluate the Effects of Intermittent Caloric Restriction in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
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) .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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A Coruña, Spain, 15006
- Jose Luis Ponce Diaz-Reixa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signature of specific informed consent for this study.
- Metabolic syndrome according to WHO criteria
- Current intake food pattern > 14 hours of duration.
- Total PSA below 2,5 ng/mL or total PSA 4 - 10 ng/mL and free/total PSA > 25%
- IPSS score > 9 points
- Maximal flow rate < 15 cc/secs
- Prostatic volume > 40 cc.
Exclusion Criteria:
- Active oncological disease; includes patients already treated without complete remission or in current active treatment.
- PSA 4 - 10 ng/mL and free/total PSA < 25% or PSA > 10 ng/mL
- Previous prostatic biopsy in the last 5 years.
- Treatment with prostatic phytotherapy in the last 4 weeks.
- BPH alphablocking treatment in the last 6 weeks.
- 5-alpha-reductase treatment in the last 6 months.
- Anticholinergic or betamimetics treatment in the last 4 weeks
- Eating, weight management disorder or previous bariatric surgery.
- Concurrent treatment with the following drugs in the fasting period: AAS and NSAIDs (except paracetamol).
- Concurrent treatment with any of the following steroids: prednisolone, budesonide, dexamethasone, fluidcortisone, hydrocortisone or prednisone.
- Major mental illness, which does not allow informed consent.
- Previous cardiovascular event in the last 12 months.
- Liver, gastrointestinal, renal or severe previous endocrine or decompensated disease in the last 12 months.
- Presence of significant vesical lithiasis.
- Type I diabetic patients
- Type II diabetic patients in treatment with sulfonylureas and sodium-glucose cotransport inhibitors, as well as in patients with insulin therapy.
- Loss of patient follow-up
- Non-compliance with protocol procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Patients in the control group will be assigned to a free diet (ad libitum), according to the Spanish Association of Urology lifestyle recommendations for patients with LUTS
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Subjects will receive diet and lifestyle recommendations from the Spanish Association of Urology, for symptoms secondary to HBP, without restriction in the meal schedule.
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Experimental: Caloric Restriction
Patients in the experimental group will be assigned to intermittent caloric restriction, based on an early time restricted eating, with a 16/8 fasting/feeding scheme. The patients in this group will have a RC progressive scheme until achieve a maximum of 5 days a week of fasting. |
Subjects will be trained to perform intermittent caloric restriction, based on an early time restricted feeding, with a 16/8 hour fasting / feeding schedule, respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the International Prostatic Symptoms Score (IPPS)
Time Frame: Change from Baseline IPPS at 36 months
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IPSS is a 7 items questionnaire (0-35 points) with 5 answers each, which analyzes the lower urinary tract symptoms.
Higher scores indicate greater symptomatology.
It is classified as mild up to 7 points, moderate 8-19 and severe greater than 20 points.
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Change from Baseline IPPS at 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Prostatic volumen
Time Frame: Change from Baseline Prostatic Volumen at 36 months
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To evaluate prostatic volumen reduction, trough transrectal sonography
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Change from Baseline Prostatic Volumen at 36 months
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Change in Insulin Resistance
Time Frame: Change from Baseline Insulin Resistance at 36 months
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To evaluate variations on insuline resistance through the HOMA-IR formula.
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Change from Baseline Insulin Resistance at 36 months
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Prostatic Specific Antigen (PSA)
Time Frame: Before and after 36 months
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To evaluate PSA variation
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Before and after 36 months
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Testosterone
Time Frame: Before and after 36 months
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To evaluate Testosterone variation
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Before and after 36 months
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IIEF5
Time Frame: Before and after 36 months
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To evaluate the International Index of Erectile Function variation
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Before and after 36 months
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Prostate Cancer
Time Frame: 36 months
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To evaluate prostate cancer incidence
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36 months
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Change in SF36 score
Time Frame: Change from Baseline SF36 questionnaire at 36 months
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To evaluate quality of life through SF36 questionnaire.
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Change from Baseline SF36 questionnaire at 36 months
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Tamsulosin prescription
Time Frame: Before and after 36 months
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To assess the incidence of the prescription of Tamsulosin for symptoms relief.
It will be analyzed as a percentage of patients with Tamsulosin prescription.
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Before and after 36 months
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Dutasteride/Finasteride prescription percentage
Time Frame: Before and after 36 months
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To assess the incidence of the prescription of Dutasteride or Finasteride for symptoms relief .
It will be analyzed as a percentage of patients with Dutasteride or Finasteride prescription.
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Before and after 36 months
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Surgery for BPH
Time Frame: Before and after 36 months
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To assess the surgical treatment needs for BPH.
It will be analyzed as a percentage of patients who are operated on by TURP or simple prostatectomy.
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Before and after 36 months
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Change in Body Mass Index (BMI) variation
Time Frame: Change from Baseline BMI at 36 months
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To evaluate variations on body mass index, measured as weight (kilograms) divided by height (cm) square.
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Change from Baseline BMI at 36 months
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Change in Abdominal perimeter variation
Time Frame: Change from Baseline abdominal perimeter variation at 36 months
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To evaluate variations on abdominal perimeter, measured as centimeters.
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Change from Baseline abdominal perimeter variation at 36 months
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Diastolic pressure variation
Time Frame: Before and after 36 months
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To evaluate variations on diastolic pressure variation, measured as mmHg.
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Before and after 36 months
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Sistolic pressure variation
Time Frame: Before and after 36 months
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To evaluate variations on sistolic pressure variation, measured as mmHg.
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Before and after 36 months
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Heart rate variation
Time Frame: Before and after 36 months
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To evaluate variations on heart rate, measured as beats per minute.
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Before and after 36 months
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Total cholesterol variation
Time Frame: Before and after 36 months
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To evaluate variations on total cholesterol, measured as mg/dL.
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Before and after 36 months
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High Density Lipoprotein cholesterol variation
Time Frame: Before and after 36 months
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To evaluate variations on HDL cholesterol, measured as mg/dL.
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Before and after 36 months
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LDL cholesterol variation
Time Frame: Before and after 36 months
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To evaluate variations on LDL cholesterol, measured as mg/dL.
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Before and after 36 months
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Triglyceride variation
Time Frame: Before and after 36 months
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To evaluate variations on triglyceride, measured as mg/dL.
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Before and after 36 months
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Alanine transaminase (ALT) variation
Time Frame: Before and after 36 months
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To evaluate variations on alanine transaminase, measured as IU.
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Before and after 36 months
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Aspartate transaminase (AST) variation
Time Frame: Before and after 36 months
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To evaluate variations on aspartate transaminase, measured as IU.
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Before and after 36 months
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HRV parameter - Parasympathetic Nervous System Index (PNS index)
Time Frame: Before and after 36 months
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To evaluate variations on PNS index, measured by heart rate variability, through Kubios software version 3.1.
PNS index includes the following measures: Mean RR, RMSSD and high frequency (HF) power
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Before and after 36 months
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HRV parameter - Sympathetic Nervous System Index (SNS index)
Time Frame: Before and after 36 months
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To evaluate variations on SNS index, measured by heart rate variability, through Kubios software version 3.1.
The SNS index includes the following measures: Mean HR, Stress index and low frequency (LF) power.
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Before and after 36 months
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HRV parameter - Low frequency / High Frequency Ratio (LF/HF ratio)
Time Frame: Before and after 36 months
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To evaluate variations on LF/HF ratio, measured by heart rate variability, through Kubios software version 3.1.
Values upper 1.6 indicates SNS predominance.
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Before and after 36 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URO - CHUAC - 002 - HBP - RC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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