Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management

Completed · Not applicable · Has a placebo group

Conditions studied: Overweight and Obesity, Body Weight Changes, Healthy Lifestyle, Exercise, Dietary Supplement

In brief

PhaoeSOL (Microphyt, Baillargues, France) is a microalgae-based nutritional ingredient developed with a patented production process that has New Dietary Ingredient (NDI) status from the FDA (#1120). It is an extract of the microalgae Phaeodactylum tricornutum standardized to 2.0% Fucoxanthin (FX) content by adding a food grade medium-chain triglyceride (MCT)-oil and a tocopherol-rich (Vitamin E) extract (0.5 % w:w). PhaeoSOL is intended for use as a source of the naturally occurring carotenoid, fucoxanthin, in food supplement products for the general population at levels not to exceed 437 mg/person/day for a maximal duration of 30 days of PhaeoSOL (equivalent to 10 mg fucoxanthin/person/day). Prior studies suggest that marine algae and Fucoxanthinol may have anti-obesity, lipid lowering, and glucose management enhancing properties. The purpose of this proof of concept pilot study is to examine whether dietary supplementation of PhaoeSOL enhances the benefits of women participating in an exercise and weight management program.

Key facts

Study ID: NCT04761406
Run by: Microphyt
People needed: 60
Starts: 2021-04-26
Expected to finish: 2023-11-01
Last updated by the study team: 2023-11-08

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Has given voluntary, written, informed consent to participate in the study;
Healthy pre-menopausal females age 18 - 50 years;
Body mass index (BMI) between 25 - 35 kg/m2 and/or body fat >30%; preferred BMI between 25-32 kg/m2; mean BMI in each group has to be in the range of 25-29.9.
Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance);
In generally good health; and,
Willing to maintain consistent sleep duration the evening before study visits.
Mean average BMI will be controlled during phone screening. Anyone with a BMI from 25-29.9 (assuming other inclusion criteria are met with no exclusion criteria) will be enrolled and a list of alternatives for borderline subjects will be kept (e.g. up to 32). A log of active participants will be kept so subjects above 30 will not be added unless the mean is within 25-29.9 range

You may not qualify if…

Are pregnant, breastfeeding, or wish to become pregnant during the study;
Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study;
Have a recent history (<3 months) of exercise training or weight loss (> 5%);
Have an orthopedic limitation that would prevent participation in a general fitness program;
Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder;
Have taken weight loss dietary supplements or medications during the last 4-wks;
Have a history of chronic use of oral or injectable corticosteroids;
Have a history within previous 12 months of alcohol or substance abuse;
Are a heavy smoking (>1 pack/day within past 3 months);
Have a history of heavy caffeinated beverage consumption (>400mg caffeine/day) within past 2 weeks; or,
Have known allergy to any of the ingredients in the supplement product or placebo.

Where it is running

Exercise & Sport Nutrition Lab — College Station, Texas, United States

Full record on ClinicalTrials.gov

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