DyslipidemiasHONEYNCT02990260
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
A study testing Saccharomyces cerevisiae and Lynside Wall Basic in people with Dyslipidemias, run by Lesaffre International at 1 site in France.
Trial summary
The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Saccharomyces cerevisiae and Lynside Wall Basic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to May 2018
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.
Who cannot join
- Total cholesterol > 3.5 g/L (on an empty stomach)
- Triglycerides > 3 g/L (on an empty stomach)
- Familial hypercholesterolemia (IIa type)
- Diabete mellitus treated or not
- Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
- Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study
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- Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study
- Subjects following a low diet regimen (intakes < 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study
- Food behaviour disorders diagnosed
- Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery
- Subjects having endure bariatric surgery or having a gastric bypass in place
- Pregnant or lactating women
- Women willing a pregnancy Excessive alcohol consumption
- Susceptible to modify their tobacco consumption before the end of the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
- Conditions
- Dyslipidemias
- Being tested
- Saccharomyces cerevisiae, Lynside Wall Basic, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiaeDietary supplement
Live Saccharomyces cerevisiae
Lynside Wall BasicDietary supplement
yeast cell walls
PlaceboDietary supplement
Maize starch and magnesium stearate
| Study group | Role | What they receive |
|---|---|---|
| Live Saccharomyces cerevisiae | Active comparator | Live Saccharomyces cerevisiae. 2 capsules per day (1 g). Receives: Dietary Supplement: Saccharomyces cerevisiae |
| Yeast cell wall | Active comparator | Yeast cell wall. 2 capsules a day (700 mg). Receives: Dietary Supplement: Lynside Wall Basic |
| Placebo | Placebo comparator | Maize starch and magnesium stearate. 2 capsules a day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma LDL cholesterol
Measured: 8 weeks
Secondary outcomes (9)
LDL cholesterol
Measured: 4 weeks
Total cholesterol
Measured: 4 weeks, 8 weeks
Triglycerides
Measured: 4 weeks, 8 weeks
HDL cholesterol
Measured: 4 weeks, 8 weeks
Apo B
Measured: 4 weeks, 8 weeks
Apo A1
Measured: 4 weeks, 8 weeks
gamma GT
Measured: 4 weeks, 8 weeks
ASAT
Measured: 4 weeks, 8 weeks
ALAT
Measured: 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990260
- Sponsor's protocol ID
- 2016-A011094-47
- Acronym
- HONEY
- Status last verified
- Jun 2018
- First submitted
- 2 Dec 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saccharomyces Cerevisiae in LDL Cholesterol
- ClinicalTrials.gov ID
- NCT02990260
- Acronym / sponsor ID
- HONEY / 2016-A011094-47
- Conditions
- Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live Saccharomyces cerevisiae | Active comparator | Dietary Supplement: Saccharomyces cerevisiaeLive Saccharomyces cerevisiae. 2 capsules per day (1 g). |
| Yeast cell wall | Active comparator | Dietary Supplement: Lynside Wall BasicYeast cell wall. 2 capsules a day (700 mg). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaize starch and magnesium stearate. 2 capsules a day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.
Key exclusion criteria (14 listed)
- Total cholesterol > 3.5 g/L (on an empty stomach)
- Triglycerides > 3 g/L (on an empty stomach)
- Familial hypercholesterolemia (IIa type)
- Diabete mellitus treated or not
- Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
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 |
|---|---|---|
| Saccharomyces cerevisiaeLive Saccharomyces cerevisiae | Dietary supplement | Live Saccharomyces cerevisiae |
| Lynside Wall Basicyeast cell walls | Dietary supplement | Yeast cell wall |
| PlaceboMaize starch and magnesium stearate | Dietary supplement | Placebo |
Primary outcome
Plasma LDL cholesterol
Time frame: 8 weeks
9 secondary outcomes
LDL cholesterol
Time frame: 4 weeks
Total cholesterol
Time frame: 4 weeks, 8 weeks
Triglycerides
Time frame: 4 weeks, 8 weeks
HDL cholesterol
Time frame: 4 weeks, 8 weeks
Apo B
Time frame: 4 weeks, 8 weeks
Apo A1
Time frame: 4 weeks, 8 weeks
gamma GT
Time frame: 4 weeks, 8 weeks
ASAT
Time frame: 4 weeks, 8 weeks
ALAT
Time frame: 4 weeks, 8 weeks
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 12 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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 Saccharomyces cerevisiae and Lynside Wall Basic in people with Dyslipidemias, run by Lesaffre International at 1 site in France.
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 1 inclusion and 14 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 12 Jun 2018. 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 France. 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.
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?
Plasma LDL cholesterol (time frame: 8 weeks). 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 12 Jun 2018.