Status:
COMPLETED
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
Lead Sponsor:
Microphyt
Collaborating Sponsors:
Texas A&M University
Conditions:
Overweight and Obesity
Body Weight Changes
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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). I...
Detailed Description
All participants will participate in a supervised exercise training 3 days per week at the HCRF consisting of a 5-min warm-up, light stretching, resistance training (3 sets of 10 repetitions @ 60%-80%...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04761406
Start Date
April 26 2021
End Date
November 1 2023
Last Update
November 8 2023
Active Locations (1)
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1
Exercise & Sport Nutrition Lab
College Station, Texas, United States, 77843-4253