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

NCT02343497 | Completed

• 1 other identifier: 2014-A00198-39
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• fasting plasma triglycerides

  g/l

  0, 12 weeks

Secondary Outcomes (19)

• fasting cholesterol

  0, 12 weeks

• fasting HDL-cholesterol

  0, 12 weeks

• fasting LDL-cholesterol

  0, 12 weeks

• apolipoprotein A1

  0, 12 weeks

• apolipoprotein B

  0, 12 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

Astaxanthin supplement from Phaffia rhodozyma, 6mg in lipid capsules, 2 caps per day, duration 12 weeks

Dietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

filling agent, in lipid capsules, 2 caps per day, duration 12 weeks

Dietary Supplement: Placebo

Interventions

Astaxanthin DIETARY_SUPPLEMENT

Astaxanthin

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajinomoto Foods Europe SAS: lead
• Institut Polytechnique LaSalle Beauvais: collaborator
• Naturalpha: collaborator

Study Sites (1)

Centre Nutrition Clinique Naturalpha

Lille, 59020, France

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 22, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

FR (1)