Prostatic Hyperplasia, BenignNCT03669692
Open Randomized Clinical Trial to Evaluate the Effects of Intermittent Caloric Restriction in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
A study testing Caloric Restriction in people with Prostatic Hyperplasia, Benign and Metabolic Syndrome, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign, Metabolic Syndrome
- What is being tested?
- Caloric Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2018to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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) .
- Conditions
- Prostatic Hyperplasia, Benign, Metabolic Syndrome
- Being tested
- Caloric Restriction, Control
- Keywords
- Prostate, Caloric Restriction, Metabolic Syndrome, Heart Rate Variability
- Medical subject headings
- Prostatic Hyperplasia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RestrictionBehavioural
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.
ControlBehavioural
Subjects will receive diet and lifestyle recommendations from the Spanish Association of Urology, for symptoms secondary to HBP, without restriction in the meal schedule.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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 Receives: Behavioral: Control |
| Caloric Restriction | Experimental | 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. Receives: Behavioral: Caloric Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the International Prostatic Symptoms Score (IPPS)
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.
Measured: Change from Baseline IPPS at 36 months
Secondary outcomes (24)
Change in Prostatic volumen
To evaluate prostatic volumen reduction, trough transrectal sonography
Measured: Change from Baseline Prostatic Volumen at 36 months
Change in Insulin Resistance
To evaluate variations on insuline resistance through the HOMA-IR formula.
Measured: Change from Baseline Insulin Resistance at 36 months
Prostatic Specific Antigen (PSA)
To evaluate PSA variation
Measured: Before and after 36 months
Testosterone
To evaluate Testosterone variation
Measured: Before and after 36 months
IIEF5
To evaluate the International Index of Erectile Function variation
Measured: Before and after 36 months
Prostate Cancer
To evaluate prostate cancer incidence
Measured: 36 months
Change in SF36 score
To evaluate quality of life through SF36 questionnaire.
Measured: Change from Baseline SF36 questionnaire at 36 months
Tamsulosin prescription
To assess the incidence of the prescription of Tamsulosin for symptoms relief. It will be analyzed as a percentage of patients with Tamsulosin prescription.
Measured: Before and after 36 months
Dutasteride/Finasteride prescription percentage
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.
Measured: Before and after 36 months
Surgery for BPH
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.
Measured: Before and after 36 months
Change in Body Mass Index (BMI) variation
To evaluate variations on body mass index, measured as weight (kilograms) divided by height (cm) square.
Measured: Change from Baseline BMI at 36 months
Change in Abdominal perimeter variation
To evaluate variations on abdominal perimeter, measured as centimeters.
Measured: Change from Baseline abdominal perimeter variation at 36 months
Diastolic pressure variation
To evaluate variations on diastolic pressure variation, measured as mmHg.
Measured: Before and after 36 months
Sistolic pressure variation
To evaluate variations on sistolic pressure variation, measured as mmHg.
Measured: Before and after 36 months
Heart rate variation
To evaluate variations on heart rate, measured as beats per minute.
Measured: Before and after 36 months
Total cholesterol variation
To evaluate variations on total cholesterol, measured as mg/dL.
Measured: Before and after 36 months
High Density Lipoprotein cholesterol variation
To evaluate variations on HDL cholesterol, measured as mg/dL.
Measured: Before and after 36 months
LDL cholesterol variation
To evaluate variations on LDL cholesterol, measured as mg/dL.
Measured: Before and after 36 months
Triglyceride variation
To evaluate variations on triglyceride, measured as mg/dL.
Measured: Before and after 36 months
Alanine transaminase (ALT) variation
To evaluate variations on alanine transaminase, measured as IU.
Measured: Before and after 36 months
Aspartate transaminase (AST) variation
To evaluate variations on aspartate transaminase, measured as IU.
Measured: Before and after 36 months
HRV parameter - Parasympathetic Nervous System Index (PNS index)
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
Measured: Before and after 36 months
HRV parameter - Sympathetic Nervous System Index (SNS index)
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.
Measured: Before and after 36 months
HRV parameter - Low frequency / High Frequency Ratio (LF/HF ratio)
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.
Measured: Before and after 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Jul 2018
- Primary completion10 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Why it stopped: No patients available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Randomized Clinical Trials
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Luis Ponce Díaz-Reixa, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669692
- Sponsor's protocol ID
- URO - CHUAC - 002 - HBP - RC
- Status last verified
- Jul 2021
- First submitted
- 9 Sep 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT03669692
- Acronym / sponsor ID
- URO - CHUAC - 002 - HBP - RC
- Conditions
- Prostatic Hyperplasia, Benign, Metabolic Syndrome
- Keywords
- Prostate, Caloric Restriction, Metabolic Syndrome, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Randomized Clinical Trials
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlPatients 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 |
| Caloric Restriction | Experimental | Behavioral: Caloric RestrictionPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric RestrictionSubjects will be trained to perform intermittent caloric restriction, based on an early time restricted feeding, with a 16/8 hour fasting / feeding schedule, respectively. | Behavioural | Caloric Restriction |
| ControlSubjects will receive diet and lifestyle recommendations from the Spanish Association of Urology, for symptoms secondary to HBP, without restriction in the meal schedule. | Behavioural | Control |
Primary outcome
Change in the International Prostatic Symptoms Score (IPPS)
Time frame: Change from Baseline IPPS at 36 months
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.
24 secondary outcomes
Change in Prostatic volumen
Time frame: Change from Baseline Prostatic Volumen at 36 months
Change in Insulin Resistance
Time frame: Change from Baseline Insulin Resistance at 36 months
Prostatic Specific Antigen (PSA)
Time frame: Before and after 36 months
Testosterone
Time frame: Before and after 36 months
IIEF5
Time frame: Before and after 36 months
Prostate Cancer
Time frame: 36 months
Change in SF36 score
Time frame: Change from Baseline SF36 questionnaire at 36 months
Tamsulosin prescription
Time frame: Before and after 36 months
Dutasteride/Finasteride prescription percentage
Time frame: Before and after 36 months
Surgery for BPH
Time frame: Before and after 36 months
Change in Body Mass Index (BMI) variation
Time frame: Change from Baseline BMI at 36 months
Change in Abdominal perimeter variation
Time frame: Change from Baseline abdominal perimeter variation at 36 months
Diastolic pressure variation
Time frame: Before and after 36 months
Sistolic pressure variation
Time frame: Before and after 36 months
Heart rate variation
Time frame: Before and after 36 months
Total cholesterol variation
Time frame: Before and after 36 months
High Density Lipoprotein cholesterol variation
Time frame: Before and after 36 months
LDL cholesterol variation
Time frame: Before and after 36 months
Triglyceride variation
Time frame: Before and after 36 months
Alanine transaminase (ALT) variation
Time frame: Before and after 36 months
Aspartate transaminase (AST) variation
Time frame: Before and after 36 months
HRV parameter - Parasympathetic Nervous System Index (PNS index)
Time frame: Before and after 36 months
HRV parameter - Sympathetic Nervous System Index (SNS index)
Time frame: Before and after 36 months
HRV parameter - Low frequency / High Frequency Ratio (LF/HF ratio)
Time frame: Before and after 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction in people with Prostatic Hyperplasia, Benign and Metabolic Syndrome, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the International Prostatic Symptoms Score (IPPS) (time frame: Change from Baseline IPPS at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.