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NCT04761406 · ClinicalTrials.gov registry record · NA
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
A NA study of Overweight and Obesity and Exercise, sponsored by Microphyt.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04761406 is a NA study of Overweight and Obesity and Exercise that has completed, run by Microphyt. The registered enrollment target is 60 participants, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04761406, a NA study of Overweight and Obesity and Exercise, has completed, sponsored by Microphyt.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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). 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Phaeosol group
- DIETARY_SUPPLEMENT Placebo group
Study Locations (1)
Texas
- Exercise & Sport Nutrition Lab - College Station
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2023-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04761406
The ClinicalTrials.gov registry entry for NCT04761406 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (74% lower). The listed sponsor is Microphyt, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 2 interventions - of which Phaeosol group is the first listed.
NCT04761406 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04761406 about?
NCT04761406 is a clinical study titled "Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management". 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) co...
What is the current status of trial NCT04761406?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-04-26. Estimated completion is 2023-11-01.
What conditions does trial NCT04761406 study?
This clinical trial studies the following conditions: Overweight and Obesity, Exercise, Healthy Lifestyle, Body Weight Changes, Dietary Supplement.
What interventions are being tested in trial NCT04761406?
The interventions under investigation include: Phaeosol group (DIETARY_SUPPLEMENT), Placebo group (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04761406?
This trial is sponsored by Microphyt, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04761406 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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