- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02343497
Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia (LLAX)
January 8, 2018 updated by: Ajinomoto Foods Europe SAS
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France, 59020
- Centre Nutrition Clinique Naturalpha
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
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),
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Astaxanthin
Astaxanthin supplement from Phaffia rhodozyma, 6mg in lipid capsules, 2 caps per day, duration 12 weeks
|
|
Placebo Comparator: Placebo
filling agent, in lipid capsules, 2 caps per day, duration 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fasting plasma triglycerides
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fasting cholesterol
Time Frame: 0, 12 weeks
|
total cholesterol (g/l)
|
0, 12 weeks
|
fasting HDL-cholesterol
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
fasting LDL-cholesterol
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
apolipoprotein A1
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
apolipoprotein B
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
apolipoprotein balance
Time Frame: 0, 12 weeks
|
Apolipoprotein B over Apolipoprotein A1 ratio
|
0, 12 weeks
|
resting blood pressure
Time Frame: 0, 6, 12 weeks
|
triplicate measure
|
0, 6, 12 weeks
|
resting heart rate
Time Frame: 0, 6, 12 weeks
|
0, 6, 12 weeks
|
|
fasting glucose
Time Frame: 0, 12 weeks
|
g/l
|
0, 12 weeks
|
fasting insulin
Time Frame: 0, 12 weeks
|
mU/l
|
0, 12 weeks
|
homeostatic model assessment to quantify insulin resistance (HOMA-IR)
Time Frame: 0, 12 weeks
|
glucose (mg/dl) * insulin(U/l) / 405
|
0, 12 weeks
|
fasting adiponectin
Time Frame: 0, 12 weeks
|
flow cytometry
|
0, 12 weeks
|
fasting leptin
Time Frame: 0, 12 weeks
|
flow cytometry
|
0, 12 weeks
|
fasting ghrelin
Time Frame: 0, 12 weeks
|
flow cytometry
|
0, 12 weeks
|
fasting resistin
Time Frame: 0, 12 weeks
|
flow cytometry
|
0, 12 weeks
|
phosphatidylcholine hydroperoxides
Time Frame: 0, 12 weeks
|
HPLC/MS
|
0, 12 weeks
|
plasmatic concentrations in astaxanthin
Time Frame: 0, 6, 12 weeks
|
HPLC/MS
|
0, 6, 12 weeks
|
compliance with study product
Time Frame: 0, 6, 12 weeks
|
accountability of returned used/unused caps
|
0, 6, 12 weeks
|
adverse events
Time Frame: during the 12 weeks of intervention
|
number of subjects with adverse events
|
during the 12 weeks of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 16, 2015
First Posted (Estimate)
January 22, 2015
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00198-39
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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