DyslipidemiasLLAXNCT02343497
Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia
A study testing Astaxanthin in people with Dyslipidemias, run by Ajinomoto Foods Europe SAS at 1 site in France.
Trial summary
The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be fulfilled at V0:
- Male and female volunteers, able to read and write, aged from 18 to 60 years inclusive at time of screening.
- Smokers and no smokers.
- Subject with a good physical condition confirmed based on the subject's interview and the clinical exam performed by the investigator.
- Subject with a Body Mass Index (BMI) ≥ 18,5 and < 35 kg/m².
- Written informed consent provided prior to screening, after receiving and understanding the subject information.
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- Stable body weight (< 3% variation) within the last 3 months prior to screening.
- Subject registered with the French Social Security, in agreement with the French law on biomedical experimentation.
- To be fulfilled before V1, randomization visit:
- Subject with fasting triglyceride concentration ≥ 1.2 and < 4 g/l.
- Subject with fasting serum LDL-cholesterol ≤ 2.2 g/l.
Who cannot join
- To be fulfilled at V0:
- Subject taking lipid altering drug therapy within 6 weeks prior to screening. Also excluded are supplements known to have significant lipid altering effects, such as:
- Phytosterols or phytostanols,
- Red yeast rice extract (Monascus purpureus),
- Beta-glucans,
- Omega-3 fatty acids (alpha-linolenic, docosahexaenoic and eicosapentaenoic),
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- Subject using the following medications: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit.
- Intake of oestroprogestative or progestative contraception started within less than three months preceding the screening visit.
- Subject taking antioxidant agents or vitamins within 6 weeks prior to screening.
- Subject taking astaxanthin-rich foods (red fish and seafood, mostly) or supplements (including krill).
- Subject following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
- Subject with any sensitivity or allergy to any of the products used in this clinical trial.
- Subject that consume more than three (3) units of alcoholic beverage daily. For the purpose of this study, a unit of alcohol is defined as 400 ml of beer, 200 ml of wine or 50 ml of hard spirits.
- Subject with known human immunodeficiency virus (HIV) seropositivity.
- Women who are pregnant or breastfeeding, or planning a pregnancy during the duration of the study.
- Female subject without efficient contraceptive method: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device or other mechanical contraception method (condom or diaphragm) or spermicide for all the duration of the study.
- Subject treated for type 1 or type 2 diabetes mellitus.
- Subject with known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by the investigator.
- Subject with symptomatic hypertension, treated or not.
- Subject treated by antivitamin K.
- Subject with history of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) and all kind of gastrointestinal surgery.
- Subject with thyroid dysfunction or treatment for this pathology.
- Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study.
- Subject with history of cancer within 5 years of screening visit (except for successfully treated basal and squamous cell carcinoma of the skin).
- Subject with any medical contraindication to blood sampling (anemia, clotting defect).
- Subject practicing intense physical activity (sport, physical exertion at work).
- Subject with history of drug abuse.
- Participation to any other clinical trial simultaneously and/or within 1 month prior to screening.
- Subject who in the opinion of the investigator have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
- Subject of legal age unable of giving consent.
- Subject deprived of liberty by judicial or administrative decision.
- Subject of legal age under legal protection.
- Subject having received over 4500 euros for clinical trial participation within the prior year including the indemnity for the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Design, Monocentric Study on Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidemia
The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.
- Conditions
- Dyslipidemias
- Being tested
- Astaxanthin, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | Astaxanthin supplement from Phaffia rhodozyma, 6mg in lipid capsules, 2 caps per day, duration 12 weeks Receives: Dietary Supplement: Astaxanthin |
| Placebo | Placebo comparator | filling agent, in lipid capsules, 2 caps per day, duration 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma triglycerides
g/l
Measured: 0, 12 weeks
Secondary outcomes (19)
fasting cholesterol
total cholesterol (g/l)
Measured: 0, 12 weeks
fasting HDL-cholesterol
g/l
Measured: 0, 12 weeks
fasting LDL-cholesterol
g/l
Measured: 0, 12 weeks
apolipoprotein A1
g/l
Measured: 0, 12 weeks
apolipoprotein B
g/l
Measured: 0, 12 weeks
apolipoprotein balance
Apolipoprotein B over Apolipoprotein A1 ratio
Measured: 0, 12 weeks
resting blood pressure
triplicate measure
Measured: 0, 6, 12 weeks
resting heart rate
Measured: 0, 6, 12 weeks
fasting glucose
g/l
Measured: 0, 12 weeks
fasting insulin
mU/l
Measured: 0, 12 weeks
homeostatic model assessment to quantify insulin resistance (HOMA-IR)
glucose (mg/dl) * insulin(U/l) / 405
Measured: 0, 12 weeks
fasting adiponectin
flow cytometry
Measured: 0, 12 weeks
fasting leptin
flow cytometry
Measured: 0, 12 weeks
fasting ghrelin
flow cytometry
Measured: 0, 12 weeks
fasting resistin
flow cytometry
Measured: 0, 12 weeks
phosphatidylcholine hydroperoxides
HPLC/MS
Measured: 0, 12 weeks
plasmatic concentrations in astaxanthin
HPLC/MS
Measured: 0, 6, 12 weeks
compliance with study product
accountability of returned used/unused caps
Measured: 0, 6, 12 weeks
adverse events
number of subjects with adverse events
Measured: during the 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionNov 2015
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajinomoto Foods Europe SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique LaSalle Beauvais, Naturalpha
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343497
- Sponsor's protocol ID
- 2014-A00198-39
- Acronym
- LLAX
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Parallel-group Design, Monocentric Study on Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidemia
- ClinicalTrials.gov ID
- NCT02343497
- Acronym / sponsor ID
- LLAX / 2014-A00198-39
- Conditions
- Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ajinomoto Foods Europe SASIndustry (pharma, biotech, devices)
- Collaborators
- Institut Polytechnique LaSalle Beauvais, Naturalpha
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Jan 2015 (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 purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: AstaxanthinAstaxanthin supplement from Phaffia rhodozyma, 6mg in lipid capsules, 2 caps per day, duration 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebofilling agent, in lipid capsules, 2 caps per day, duration 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female volunteers, able to read and write, aged from 18 to 60 years inclusive at time of screening.
- Smokers and no smokers.
- Subject with a good physical condition confirmed based on the subject's interview and the clinical exam performed by the investigator.
- Subject with a Body Mass Index (BMI) ≥ 18,5 and < 35 kg/m².
- Written informed consent provided prior to screening, after receiving and understanding the subject information.
Key exclusion criteria (33 listed)
- Subject taking lipid altering drug therapy within 6 weeks prior to screening. Also excluded are supplements known to have significant lipid altering effects, such as:
- Subject using the following medications: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit.
- Intake of oestroprogestative or progestative contraception started within less than three months preceding the screening visit.
- Subject taking antioxidant agents or vitamins within 6 weeks prior to screening.
- Subject taking astaxanthin-rich foods (red fish and seafood, mostly) or supplements (including krill).
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 |
|---|---|---|
| Astaxanthin | Dietary supplement | Astaxanthin |
| Placebo | Dietary supplement | Placebo |
Primary outcome
fasting plasma triglycerides
Time frame: 0, 12 weeks
g/l
19 secondary outcomes
fasting cholesterol
Time frame: 0, 12 weeks
fasting HDL-cholesterol
Time frame: 0, 12 weeks
fasting LDL-cholesterol
Time frame: 0, 12 weeks
apolipoprotein A1
Time frame: 0, 12 weeks
apolipoprotein B
Time frame: 0, 12 weeks
apolipoprotein balance
Time frame: 0, 12 weeks
resting blood pressure
Time frame: 0, 6, 12 weeks
resting heart rate
Time frame: 0, 6, 12 weeks
fasting glucose
Time frame: 0, 12 weeks
fasting insulin
Time frame: 0, 12 weeks
homeostatic model assessment to quantify insulin resistance (HOMA-IR)
Time frame: 0, 12 weeks
fasting adiponectin
Time frame: 0, 12 weeks
fasting leptin
Time frame: 0, 12 weeks
fasting ghrelin
Time frame: 0, 12 weeks
fasting resistin
Time frame: 0, 12 weeks
phosphatidylcholine hydroperoxides
Time frame: 0, 12 weeks
plasmatic concentrations in astaxanthin
Time frame: 0, 6, 12 weeks
compliance with study product
Time frame: 0, 6, 12 weeks
adverse events
Time frame: during the 12 weeks of intervention
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 9 Jan 2018.
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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 Astaxanthin in people with Dyslipidemias, run by Ajinomoto Foods Europe SAS 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 11 inclusion and 33 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 9 Jan 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?
fasting plasma triglycerides (time frame: 0, 12 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 9 Jan 2018.