Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia

Dyslipidemias Clinical Trial

— LLAX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343497
• Other study ID #: 2014-A00198-39
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: January 8, 2018
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2018
• Source: Ajinomoto Foods Europe SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

To be fulfilled at V0:

1. Male and female volunteers, able to read and write, aged from 18 to 60 years inclusive at time of screening.

2. Smokers and no smokers.

3. Subject with a good physical condition confirmed based on the subject's interview and the clinical exam performed by the investigator.

4. Subject with a Body Mass Index (BMI) = 18,5 and < 35 kg/m².

5. Written informed consent provided prior to screening, after receiving and understanding the subject information.

6. Stable body weight (< 3% variation) within the last 3 months prior to screening.

7. Subject registered with the French Social Security, in agreement with the French law on biomedical experimentation.

To be fulfilled before V1, randomization visit:

8. Subject with fasting triglyceride concentration = 1.2 and < 4 g/l.

9. Subject with fasting serum LDL-cholesterol = 2.2 g/l.

Exclusion Criteria:

To be fulfilled at V0:

1. 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),

2. 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.

3. Intake of oestroprogestative or progestative contraception started within less than three months preceding the screening visit.

4. Subject taking antioxidant agents or vitamins within 6 weeks prior to screening.

5. Subject taking astaxanthin-rich foods (red fish and seafood, mostly) or supplements (including krill).

6. Subject following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.

7. Subject with any sensitivity or allergy to any of the products used in this clinical trial.

8. 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.

9. Subject with known human immunodeficiency virus (HIV) seropositivity.

10. Women who are pregnant or breastfeeding, or planning a pregnancy during the duration of the study.

11. 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.

12. Subject treated for type 1 or type 2 diabetes mellitus.

13. Subject with known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by the investigator.

14. Subject with symptomatic hypertension, treated or not.

15. Subject treated by antivitamin K.

16. 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.

17. Subject with thyroid dysfunction or treatment for this pathology.

18. Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study.

19. Subject with history of cancer within 5 years of screening visit (except for successfully treated basal and squamous cell carcinoma of the skin).

20. Subject with any medical contraindication to blood sampling (anemia, clotting defect).

21. Subject practicing intense physical activity (sport, physical exertion at work).

22. Subject with history of drug abuse.

23. Participation to any other clinical trial simultaneously and/or within 1 month prior to screening.

24. 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.

25. Subject of legal age unable of giving consent.

26. Subject deprived of liberty by judicial or administrative decision.

27. Subject of legal age under legal protection.

28. Subject having received over 4500 euros for clinical trial participation within the prior year including the indemnity for the present study.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Dietary Supplement:
• Astaxanthin

• Placebo

Locations

Country	Name	City	State
France	Centre Nutrition Clinique Naturalpha	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Ajinomoto Foods Europe SAS	Institut Polytechnique LaSalle Beauvais, Naturalpha

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting plasma triglycerides	g/l	0, 12 weeks
Secondary	fasting cholesterol	total cholesterol (g/l)	0, 12 weeks
Secondary	fasting HDL-cholesterol	g/l	0, 12 weeks
Secondary	fasting LDL-cholesterol	g/l	0, 12 weeks
Secondary	apolipoprotein A1	g/l	0, 12 weeks
Secondary	apolipoprotein B	g/l	0, 12 weeks
Secondary	apolipoprotein balance	Apolipoprotein B over Apolipoprotein A1 ratio	0, 12 weeks
Secondary	resting blood pressure	triplicate measure	0, 6, 12 weeks
Secondary	resting heart rate		0, 6, 12 weeks
Secondary	fasting glucose	g/l	0, 12 weeks
Secondary	fasting insulin	mU/l	0, 12 weeks
Secondary	homeostatic model assessment to quantify insulin resistance (HOMA-IR)	glucose (mg/dl) * insulin(U/l) / 405	0, 12 weeks
Secondary	fasting adiponectin	flow cytometry	0, 12 weeks
Secondary	fasting leptin	flow cytometry	0, 12 weeks
Secondary	fasting ghrelin	flow cytometry	0, 12 weeks
Secondary	fasting resistin	flow cytometry	0, 12 weeks
Secondary	phosphatidylcholine hydroperoxides	HPLC/MS	0, 12 weeks
Secondary	plasmatic concentrations in astaxanthin	HPLC/MS	0, 6, 12 weeks
Secondary	compliance with study product	accountability of returned used/unused caps	0, 6, 12 weeks
Secondary	adverse events	number of subjects with adverse events	during the 12 weeks of intervention