HypercholesterolemiaPhase 4ReducolNCT03550287
Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia
A Phase 4 study testing Experimental product in people with Hypercholesterolemia and Hyperlipidemias, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Dietary Supplements
- What is being tested?
- Experimental product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2017to 31 Dec 2017
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 65 years old.
- BMI ≥18.5 and <30 kg/m2.
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent.
- Cardiovascular risk <10% to 10 years measured by REGICOR.
- Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:
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- ≥ 45 years or women ≥ 55 years.
- Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
- HDL cholesterol: men <40 or women <50.
- Triglycerides ≥ 150mg/dL and <200 mg/dL
- LDL cholesterol ≥ 130mg/dL and < 160mg/dL
- Smoker
- Willingness to follow a healthy diet, hyperlipidemic control diet and a diet without stanols, sterols and yeast.
- Social or familiar environment that prevents from accomplishing the dietary treatment
Who cannot join
- Individuals diagnosed with Diabetes Mellitus type 1.
- Individuals diagnosed with Diabetes Mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials).
- Individuals with dyslipidemia on pharmacological treatment;
- Individuals with hypertension on pharmacological treatment;
- Individuals > 60 years smokers with total cholesterol > 200mg/dL or LDL >130mg/dl.
- Individuals with hypertension on pharmacological treatment uncontrolled.
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- Individuals with hyperthyroidism and hypothyroidism on pharmacological treatment uncontrolled.
- Individuals allergic to Shiitake (Lentinula edodes)
- Individuals with chronic diseases (hepatic, kidney, …)
- Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs);
- Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
- Smokers wanting to stop to smoke during the period that clinical trial lasts.
- Individuals with mental illness.
- Consume drugs to lose weight during 30 days before starting the study
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate the Effect of a Shiitake Mushroom Extract Supplement on Lipid Profile, Other Cardiovascular Risk Factors and the Microbiota in Subjects With and Moderate Hyperlipidemia
Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.
Read the detailed description
Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2) Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.
- Being tested
- Experimental product, Placebo product
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental productDietary supplement
10 g/day
Placebo productDietary supplement
10 g/day
| Study group | Role | What they receive |
|---|---|---|
| Experimental product | Experimental | Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks. Receives: Dietary Supplement: Experimental product |
| Placebo product | Placebo comparator | Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks. Receives: Dietary Supplement: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Total Cholesterol
Total Cholesterol
Measured: Week 0 and 8
Secondary outcomes (14)
Change from Baseline Lipid Metabolism Parameters
High Density Lipoprotein
Measured: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Low Density Lipoprotein
Measured: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Triglycerides
Measured: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
Measured: Week 0 and 8
Change from Baseline Satiety Hunger Assessment
Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.
e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.
Measured: Week 0 and 8
Total amount of food consumed in 24h
24h Food Record Method
Measured: Week 0 and 8
Change from Baseline Vitamin D
Vitamin D
Measured: Week 0 and 8
Change from Baseline Anthropometric Parameters
Weight and Height to calcule BMI in kg/m2
Measured: Week 0 and 8
Change from Baseline Anthropometric Parameters
Waist Circumference
Measured: Week 0 and 8
Sensory Perception
Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.
Measured: Week 4
Change from Baseline Glucose Parameters
Glucose
Measured: Week 0 and 8
Change from Baseline Inflammation Parameters
PCR, fibrinogen, IL-6, IL-10, TNFalpha
Measured: Week 0 and 8
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: Week 0, 4 and 8
Change from Baseline Markers of oxidation
LDLox
Measured: Week 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start8 May 2017
- Primary completion30 Jun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, PhD, MS, Principal investigator, Institute for Health Research IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550287
- Sponsor's protocol ID
- 4813
- Acronym
- Reducol
- Status last verified
- Apr 2018
- First submitted
- 8 May 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effect of a Shiitake Mushroom Extract Supplement on Lipid Profile, Other Cardiovascular Risk Factors and the Microbiota in Subjects With and Moderate Hyperlipidemia
- ClinicalTrials.gov ID
- NCT03550287
- Acronym / sponsor ID
- Reducol / 4813
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 Jun 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.
Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.
Detailed description
Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2) Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental product | Experimental | Dietary Supplement: Experimental productDietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks. |
| Placebo product | Placebo comparator | Dietary Supplement: Placebo productIsocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women from 18 to 65 years old.
- BMI ≥18.5 and <30 kg/m2.
- Adequate cultural level and understanding for the clinical trial.
- Signed informed consent.
- Cardiovascular risk <10% to 10 years measured by REGICOR.
Key exclusion criteria (15 listed)
- Individuals diagnosed with Diabetes Mellitus type 1.
- Individuals diagnosed with Diabetes Mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials).
- Individuals with dyslipidemia on pharmacological treatment;
- Individuals with hypertension on pharmacological treatment;
- Individuals > 60 years smokers with total cholesterol > 200mg/dL or LDL >130mg/dl.
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 |
|---|---|---|
| Experimental product10 g/day | Dietary supplement | Experimental product |
| Placebo product10 g/day | Dietary supplement | Placebo product |
Primary outcome
Change from Baseline Total Cholesterol
Time frame: Week 0 and 8
Total Cholesterol
14 secondary outcomes
Change from Baseline Lipid Metabolism Parameters
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Time frame: Week 0 and 8
Change from Baseline Satiety Hunger Assessment
Time frame: Week 0 and 8
Total amount of food consumed in 24h
Time frame: Week 0 and 8
Change from Baseline Vitamin D
Time frame: Week 0 and 8
Change from Baseline Anthropometric Parameters
Time frame: Week 0 and 8
Change from Baseline Anthropometric Parameters
Time frame: Week 0 and 8
Sensory Perception
Time frame: Week 4
Change from Baseline Glucose Parameters
Time frame: Week 0 and 8
Change from Baseline Inflammation Parameters
Time frame: Week 0 and 8
Adverse Effects
Time frame: Week 0, 4 and 8
Change from Baseline Markers of oxidation
Time frame: Week 0 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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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.
Carmen Gómez Candela, PhD, MS principal investigator
Institute for Health Research IdiPAZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental product in people with Hypercholesterolemia and Hyperlipidemias, run by Instituto de Investigación Hospital Universitario La Paz 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 14 inclusion and 15 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: finished, as of the sponsor's last update on 13 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Total Cholesterol (time frame: Week 0 and 8). 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 13 Jan 2022.